Delivery of medical devices and consumables for the needs of UMBAL "Alexandrovska" EAD. This public procurement will assign 16 separate lots from No. 1 to No. 16, inclusive. The delivery period for the execution of the public procurement is 24 months, starting from the date of signing the contract, through periodic deliveries based on preliminary requests by type and quantity. Delivery period – Up to 7 (seven) calendar days from the date of receipt of the request from the Contracting Authority. The medical devices and consumables subject to this procurement are detailed with technical requirements, unit of measurement, and necessary forecast quantity for the duration of the contract in the attached "Technical Specification" – Appendix No. 1. The conditions for execution are according to the attached draft contract.

LOT-0001
Tests and kits for microbiology laboratory.
№ / Name / Description / Measure / Forecast quantity for 24 months 1. Immunochromatographic rapid test AGM LFA for the qualitative detection of galactomannan from Aspergillus spp. in serum and bronchoalveolar lavage fluid (BAL). It uses the "sandwich" method with colloidal gold conjugate and provides results within 30 minutes through visual reading. The test shows high sensitivity and specificity for serum samples, with up to 100% sensitivity and 97% specificity visually. The kit contains 50 test strips and requires pre-thermal treatment of the samples at 120°C for 6-8 minutes, followed by centrifugation and mixing with reagents. Package of 50 tests - package - 4 2. VoTіsk rapid test for direct detection of Borrelia antigens (B. garinii, B. afzelii, B. burgdorferi sensu stricto, and B. spielmanii) from ticks. The test is suitable for examination of small to medium-sized ticks (≤8mm). A positive result from the test indicates that the examined tick is a carrier of Borrelia. The test has a sensitivity of 90.00% and specificity of 97.75% for Borrelia sp. For a positive result, two red lines appear in the reaction field of the VoTіsk test cassette. Package of 10 tests - package - 20 3. Kit for detection of pathogens of infections through Real-Time PCR - Aspergillus fumigatus, Aspergillus flavus, Aspergillus terreus in clinical samples from bronchoalveolar lavage, bronchoalveolar aspirate, and sputum. The kit contains all necessary components for the reaction – specific primers and probes, dNTPs, buffer, polymerase. All reagents are provided in a stabilized and ready-to-use format for easy and quick use – lyophilized and pre-applied in PCR tubes. The kit allows for target differentiation and internal control using the following detection channels: FAM, HEX, ROX, Cy5. The kit comes with positive and negative controls. Package of 96 reactions. CE-IVD. - package - 2 4. Kit for detection of the infectious agent through Real-Time PCR: Pneumocystis jirovecii in respiratory samples. The kit contains all necessary components for the reaction – specific primers and probes, dNTPs, buffer, polymerase. All reagents are provided in a stabilized and ready-to-use format for easy and quick use – lyophilized and pre-applied in PCR tubes. The kit allows for target differentiation and internal control using the following detection channels: FAM, HEX. The kit comes with positive and negative controls. Package of 96 reactions. CE-IVD. - package - 2 It is mandatory that the offer for the separate lot is complete – the participant offers all nomenclature units from the position. Everywhere in the Specification, where a specific model, source, process, trademark, type, origin, or production is indicated that would lead to the advantage or elimination of certain persons or products, it should be read and understood as "or equivalent". Requirements for supplied medical devices and participants: 1. The offered medical devices must comply with the requirements of the Medical Device Act /MDA/ - declared in the technical proposal of the participant; 2. Medical devices must have a Declaration of Conformity for the offered medical devices/Certificate or equivalent documents for compliance with the applicable EU Directive / Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, Directive 93/42 EEC or Directive 98/79 EC for in vitro diagnostic medical products, issued by a notified body under MDA /or equivalent/; 3. The medical device must have a Quality Certificate - CE marking, in accordance with the applicable EU directive /or equivalent/. The participant declares compliance with points 2 and 3 in their technical proposal. In case no Declaration of Conformity and/or certificate for "CE" marking is required by law/directive for a specific medical device, the participant submits a declaration in free text, declaring this fact. The selected contractor, before signing the contract, presents a Declaration of Conformity for the offered medical devices /Certificate or equivalent documents for compliance with the applicable EU Directive - Directive 93/42 EEC or Directive 98/79 EC for in vitro diagnostic medical products, Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, issued by a notified body under MDA, EU certificate for CE marking on the product or equivalent document in accordance with the requirements of Articles 8 and 15 of the MDA with a translation into Bulgarian. 4. The shelf life of medical devices should not be less than 6 (six) months from the date of the acceptance-record for their delivery; 5. The participant must provide catalogs, brochures, information sheets or equivalent to the offered medical devices, in which there is detailed information about them translated into Bulgarian, from which all indicators and production characteristics can be clearly demonstrated, proving the quality of the offered product and its compliance with technical specifications and apparatus. 6. The indicated quantities by separate lots are forecasted and should not be interpreted as an obligation for the Contracting Authority for the minimum or maximum total quantity (within the duration of the contract) for the indicated medical devices. If necessary, the requested quantities may be exceeded.

LOT-0002
Separate lot No. 2 Consumables compatible with mass spectrometer MALDI TOF EXS 2600.
№ / Name / Description / Measure / Forecast quantity for 24 months 1. Matrix solution for processing and identification of microbial samples, containing α-Cyano-4-hydroxycinnamic acid 5 vials of 100 µl - Package 500 tests - 50 2. Solution for pre-processing of microbial samples based on 70% Formic acid – 5 vials of 100 μL - Package 500 tests - 15 3. Kit for pre-processing of microbial samples, containing (Microbial lysate I based on 70% Formic acid 2 vials of 1000 μl; Microbial lysate II based on Acetonitrile 2 vials of 1000 μl; Matrix solution for processing and identification of samples based on α-Cyano-4-hydroxycinnamic acid 1 vial of 100 µl) - Package 100 tests - 5 4. Kit for pre-processing of a positive sample of hemoculture, containing (Cleaning buffer I based on Urea - 3 vials of 8.5 ml; Cleaning buffer II based on Sodium azide - 3 vials of 8.5 ml; Lysis buffer based on Saponin - 6 vials of 1.7 ml) - Package 50 tests - 5 5. Kit for pre-processing of mold fungi, containing (Extraction reagent for molds I based on Formic acid - 1 vial of 10 mL; Extraction reagent for molds II based on Acetonitrile - 1 vial of 10 mL; Matrix solution based on α-Cyano-4-hydroxycinnamic acid - 1 vial of 50 μL; 50 extraction vials for mold fungi; 50 sample swabs) - Package 50 tests - 7 6. Microbiological calibrator, containing (Microbiological calibrator based on protein extracts from E. coli - 4 lyophilized vials of 20 tests; Solvent for microbiological calibrator based on Formic acid and Acetonitrile - 1 vial of 150 μL - Package 80 tests - 4 7. Target plate with 96 positions for multiple use - Package of 2 plates - 1 8. Holder for target plate - Package of 1 piece - 1 It is mandatory that the offer for the separate lot is complete – the participant offers all nomenclature units from the position. Everywhere in the Specification, where a specific model, source, process, trademark, type, origin, or production is indicated that would lead to the advantage or elimination of certain persons or products, it should be read and understood as "or equivalent". Requirements for supplied medical devices and participants: 1. The offered medical devices must comply with the requirements of the Medical Device Act /MDA/ - declared in the technical proposal of the participant; 2. Medical devices must have a Declaration of Conformity for the offered medical devices/Certificate or equivalent documents for compliance with the applicable EU Directive / Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, Directive 93/42 EEC or Directive 98/79 EC for in vitro diagnostic medical products, issued by a notified body under MDA /or equivalent/; 3. The medical device must have a Quality Certificate - CE marking, in accordance with the applicable EU directive /or equivalent/. The participant declares compliance with points 2 and 3 in their technical proposal. In case no Declaration of Conformity and/or certificate for "CE" marking is required by law/directive for a specific medical device, the participant submits a declaration in free text, declaring this fact. The selected contractor, before signing the contract, presents a Declaration of Conformity for the offered medical devices /Certificate or equivalent documents for compliance with the applicable EU Directive - Directive 93/42 EEC or Directive 98/79 EC for in vitro diagnostic medical products, Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, issued by a notified body under MDA, EU certificate for CE marking on the product or equivalent document in accordance with the requirements of Articles 8 and 15 of the MDA with a translation into Bulgarian. 4. The shelf life of medical devices should not be less than 6 (six) months from the date of the acceptance-record for their delivery; 5. The participant must provide catalogs, brochures, information sheets or equivalent to the offered medical devices, in which there is detailed information about them translated into Bulgarian, from which all indicators and production characteristics can be clearly demonstrated, proving the quality of the offered product and its compliance with technical specifications and apparatus. 6. The indicated quantities by separate lots are forecasted and should not be interpreted as an obligation for the Contracting Authority for the minimum or maximum total quantity (within the duration of the contract) for the indicated medical devices. If necessary, the requested quantities may be exceeded.

LOT-0003
Kits for HLA typing through next-generation sequencing for Ion Torrent* platform.
No       /  Name                       Description       /  unit /Forecast quantity for 24 months
1. Kit for preparation of libraries for next generation sequencing through semiconductor detection-kit-10
2. Kit for preparation of matrix for next generation sequencing through semiconductor detection IonChef*-kit-10
3. Sequencing kit for next generation sequencing through semiconductor detection for S5 Ion Torrent*-kit-10
4. Set of primers for multiplex next generation sequencing-set-5
5. Reagents for purification of DNA libraries for next generation sequencing AmPure - 60 ml/pack*-package-3
6. Chips for next generation sequencing through semiconductor detection of S5 Ion Torrent*, 4 pieces per package-package-5
7. Kit for highly specific measurement of concentration from double-stranded DNA for Qubit device-kit-30
8. Tubes for Qubit device - 500 μl, 500 pcs./pack.-package-10
9. Kit for HLA typing (HLA-A,-B,-C, DRB, -DQ,-DP loci) for next generation sequencing system through semiconductor detection Ion Torrent including amplification module, library preparation and sequencing*-test-960

It is mandatory for the proposal under the specific position to be complete – the participant offers all items from the position. Everywhere in the specification, where a specific model, source, process, brand, type, origin or production is mentioned, which would lead to the advantage or elimination of certain persons or products, it should be read and understood as "or equivalent".
1. The participant who wins specific position No.3 must provide the necessary equipment for the lonChef and S5 for the duration of the contract, for which the contracting authority does not owe remuneration.
2. The participant who wins the specific position must ensure maintenance of the provided equipment by trained and certified by the manufacturer or authorized person - at least two service engineers, with a response time to an issue of up to 4 hours. The circumstances under points 1 and 2 are declared in the technical proposal of the participant. The selected contractor must present a list of service engineers accompanied by evidence of their professional qualifications before the conclusion of the contract.
Requirements for the delivered medical supplies and participants:
1. The offered medical supplies must meet the requirements of the Medical Devices Act (MDA) - declared in the technical proposal of the participant;
2. Medical devices must have a Declaration of Conformity for the offered medical devices/Certificate or equivalent documents for compliance with applicable EU Directive / Regulation (EU) 2017/745 of the European Parliament and the Council of April 5, 2017 for medical devices, Directive 93/42 EEC or Directive 98/79 EC for in vitro diagnostic medical products, issued by a notified body within the meaning of the MDA / or equivalent/;
3. The medical device must have a Certificate of Quality - CE marking, in accordance with the applicable EU directive / or equivalent/; The participant declares compliance under points 2 and 3 in its technical proposal.
In the event that a specific medical device is not legally required a Declaration of Conformity and/or “CE” certificate, the participant must provide a declaration in free text, declaring this circumstance. The selected contractor, before concluding the contract, must present a Declaration of Conformity of the offered medical devices / Certificate or equivalent documents for compliance with the applicable EU Directive - Directive 93/42 EEC or Directive 98/79 EC for in vitro diagnostic medical products, Regulation (EU) 2017/745 of the European Parliament and the Council of April 5, 2017 for medical devices, issued by a notified body within the meaning of the MDA, EU certificate of the applied CE marking on the product or equivalent document in accordance with the requirements of Art.8 and Art.15 of the MDA with a translation into Bulgarian.
4. The shelf life of the medical devices must be no shorter than 6 (six) months, counting from the date of the acceptance report for their delivery;
5. The participant must provide catalogs, brochures, data sheets or equivalent with the offered medical devices, containing detailed information about them translated into Bulgarian and which visibly show all indicators and manufacturing characteristics, from which the quality of the offered product and its compliance with the technical specifications and equipment are indisputably proven.
6. The stated quantities for individual specific positions are forecasts and should not be interpreted as the contracting authority's obligation for a minimal or maximal total quantity (within the duration of the contract) of the stated medical devices. If necessary, the requested quantities may be exceeded.

LOT-0004
Kinetic test for determining Endotoxins in injection solutions.
No       /  Name                       Description    /  unit /Forecast quantity for 24 months
1. Kinetic test for determining Endotoxins in injection solutions
Minimum sensitivity threshold: from 0.005 EU/mL to 50 EU/mL
Package: 192 tests/ for 48 samples
Results: Quantitative
Standards for building a standard curve: from 3 to 5 point construction in repeatability
Negative control – in repeatability
Internal control: At least one set of spiked samples in repeatability
Test should be compatible with available laboratory reporting device ELx808LBS and software for analysis WinKQCL in accordance with the required pharmacopoeial software 21 CFR Part 11 - endotoxin detection analysis software.
The kit must contain:
8 x 24 tests Lysis, 2 endotoxin tubes, 50 EU/ml, 3 x 30 ml LAL water

Everywhere in the specification, where a specific model, source, process, brand, type, origin or production is mentioned, which would lead to the advantage or elimination of certain persons or products, it should be read and understood as "or equivalent".
Requirements for the delivered medical supplies and participants:
1. The offered medical supplies must meet the requirements of the Medical Devices Act (MDA) - declared in the technical proposal of the participant;
2. Medical devices must have a Declaration of Conformity for the offered medical devices/Certificate or equivalent documents for compliance with applicable EU Directive / Regulation (EU) 2017/745 of the European Parliament and the Council of April 5, 2017 for medical devices, Directive 93/42 EEC or Directive 98/79 EC for in vitro diagnostic medical products, issued by a notified body within the meaning of the MDA / or equivalent/;
3. The medical device must have a Certificate of Quality - CE marking, in accordance with the applicable EU directive / or equivalent/; The participant declares compliance under points 2 and 3 in its technical proposal.
In the event that a specific medical device is not legally required a Declaration of Conformity and/or “CE” certificate, the participant must provide a declaration in free text, declaring this circumstance. The selected contractor, before concluding the contract, must present a Declaration of Conformity of the offered medical devices / Certificate or equivalent documents for compliance with the applicable EU Directive - Directive 93/42 EEC or Directive 98/79 EC for in vitro diagnostic medical products, Regulation (EU) 2017/745 of the European Parliament and the Council of April 5, 2017 for medical devices, issued by a notified body within the meaning of the MDA, EU certificate of the applied CE marking on the product or equivalent document in accordance with the requirements of Art.8 and Art.15 of the MDA with a translation into Bulgarian.
4. The shelf life of the medical devices must be no shorter than 6 (six) months, counting from the date of the acceptance report for their delivery;
5. The participant must provide catalogs, brochures, data sheets or equivalent with the offered medical devices, containing detailed information about them translated into Bulgarian and which visibly show all indicators and manufacturing characteristics, from which the quality of the offered product and its compliance with the technical specifications and equipment are indisputably proven.
6. The stated quantities for individual specific positions are forecasts and should not be interpreted as the contracting authority's obligation for a minimal or maximal total quantity (within the duration of the contract) of the stated medical devices. If necessary, the requested quantities may be exceeded.

LOT-0005
Consumables for the Stellaris device.
No       /  Name                       Description    /  unit /Forecast quantity for 24 months
1. Combined package compatible with the Stellaris device including (1 cassette, 1 silicone tip, 1 test, 1 phaco key). -number - 24
2. Vitrectomy cutter Vitectomy cutter, with a maximum cutting speed of 7500 cut/minute, compatible with Stellaris device-number-24
3. Vitrectomy cutter Vitectomy cutter bi-blade, with a maximum cutting speed of 15000 cut/minute, compatible with Stellaris device-number-12
4. Endo illumination, compatible with Stellaris WideField 23G-number-24
5. Phaco package compatible with the Stellaris device including (1 cassette, 1 silicone tip, 1 test, 1 phaco key).-number-24
6. Set of trocars 23G with valves and infusion line -number -24
7. Fluid extraction system (including aspiration line + syringe+ 23G cannula+ 25G cannula). -number - 12
8. Silicone tip for phaco tip+ test chamber (single-use) 2.6-2.8 mm -number - 48
9. Phaco type needle compatible with the Stellaris device for single-use - 30* (2.5 mm - 2.6 mm) -number - 36
10. Tweezers for endo diathermy REUSABLE BIPOLAR 25GA, compatible with Stellaris device -number - 2

It is mandatory for the proposal under the specific position to be complete – the participant offers all items from the position. Everywhere in the specification, where a specific model, source, process, brand, type, origin or production is mentioned, which would lead to the advantage or elimination of certain persons or products, it should be read and understood as "or equivalent".
Requirements for the delivered medical supplies and participants:
1. The offered medical supplies must meet the requirements of the Medical Devices Act (MDA) - declared in the technical proposal of the participant;
2. Medical devices must have a Declaration of Conformity for the offered medical devices/Certificate or equivalent documents for compliance with applicable EU Directive / Regulation (EU) 2017/745 of the European Parliament and the Council of April 5, 2017 for medical devices, Directive 93/42 EEC or Directive 98/79 EC for in vitro diagnostic medical products, issued by a notified body within the meaning of the MDA / or equivalent/;
3. The medical device must have a Certificate of Quality - CE marking, in accordance with the applicable EU directive / or equivalent/; The participant declares compliance under points 2 and 3 in its technical proposal.
In the event that a specific medical device is not legally required a Declaration of Conformity and/or “CE” certificate, the participant must provide a declaration in free text, declaring this circumstance. The selected contractor, before concluding the contract, must present a Declaration of Conformity of the offered medical devices / Certificate or equivalent documents for compliance with the applicable EU Directive - Directive 93/42 EEC or Directive 98/79 EC for in vitro diagnostic medical products, Regulation (EU) 2017/745 of the European Parliament and the Council of April 5, 2017 for medical devices, issued by a notified body within the meaning of the MDA, EU certificate of the applied CE marking on the product or equivalent document in accordance with the requirements of Art.8 and Art.15 of the MDA with a translation into Bulgarian.
4. The shelf life of the medical devices must be no shorter than 6 (six) months, counting from the date of the acceptance report for their delivery;
5. The participant must provide catalogs, brochures, data sheets or equivalent with the offered medical devices, containing detailed information about them translated into Bulgarian and which visibly show all indicators and manufacturing characteristics, from which the quality of the offered product and its compliance with the technical specifications and equipment are indisputably proven.
6. The stated quantities for individual specific positions are forecasts and should not be interpreted as the contracting authority's obligation for a minimal or maximal total quantity (within the duration of the contract) of the stated medical devices. If necessary, the requested quantities may be exceeded.

LOT-0006
Blood pressure measurement cuffs.
№ / Name / Description / unit / Estimated quantity for 24 months
1. Blood pressure measuring cuffs in sizes M and L, for patient monitor Mindray - pieces - 62
2. Blood pressure measuring cuffs for monitors for anesthetic apparatus Medek: Cuff sizes M, L, XL. - pieces - 9
It is mandatory that the completeness of the offer for the specified position is ensured - the participant offers all nomenclature units from the position.
Everywhere in the Specification, where a specific model, source, process, trademark, type, origin, or production is indicated, which would lead to the advantage or elimination of certain persons or products, it should be read and understood as 'or equivalent'.
Requirements for the delivered medical products and participants:
1. The offered medical products must comply with the requirements of the Medical Devices Act (ZMI) - this must be declared in the technical proposal of the participant;
2. The medical products must have a Declaration of Conformity for the offered medical products/Certificate or equivalent documents confirming compliance with the applicable EU Directive / Regulation (EU) 2017/745 of the European Parliament and of the Council of April 5, 2017 for medical devices, Directive 93/42 EEC or Directive 98/79 EC for in-vitro diagnostic medical products, issued by a notified body under the ZMI / or equivalent;
3. The medical product must possess a quality certificate - CE marking, in accordance with the applicable EU directive / or equivalent;
The participant declares compliance under points 2 and 3 in their technical proposal.
If a specific medical product is not required by law/directive a Declaration of Conformity and/or certificate for 'CE' marking, the participant applies a free-text declaration, in which they declare this circumstance.
The selected contractor, before signing the contract, submits a Declaration of Conformity for the offered medical products / Certificate or equivalent documents confirming compliance with the applicable EU Directive - Directive 93/42 EEC or Directive 98/79 EC for in-vitro diagnostic medical products, Regulation (EU) 2017/745 of the European Parliament and of the Council of April 5, 2017 for medical devices, issued by a notified body under the ZMI, EU certificate for the applied 'CE' marking on the product or equivalent document in accordance with the requirements of Art.8 and Art.15 of ZMI with a translation into Bulgarian.
4. The shelf life of the medical products should not be less than 6 (six) months from the date of the acceptance-protocol for their delivery;
5. The participant must submit catalogs, brochures, information sheets, or equivalent with the offered medical products, in which detailed information about them should be included with a translation also in Bulgarian, from which all indicators and production characteristics can be clearly seen, proving the quality of the offered product and its compliance with technical specifications and equipment.
6. The quantities indicated for individual specified positions are estimated and should not be interpreted as an obligation of the Contracting Authority for a minimum or maximum total quantity (within the contractual duration) of the specified medical products. If necessary, the stated quantities may be exceeded.

LOT-0007
Abdominal drains.
№ / Name / Description / unit / Estimated quantity for 24 months
1. Silicon abdominal drain with 5 side holes and one central opening, without RKN, length 50cm. - CH15 - pieces - 2000
2. Silicon abdominal drain with 5 side holes and one central opening, without RKN, length 50cm. - CH18 - pieces - 2000
3. Silicon abdominal drain with 5 side holes and one central opening, without RKN, length 50cm. - CH21 - pieces - 2000
It is mandatory that the completeness of the offer for the specified position is ensured - the participant offers all nomenclature units from the position.
Everywhere in the Specification, where a specific model, source, process, trademark, type, origin, or production is indicated, which would lead to the advantage or elimination of certain persons or products, it should be read and understood as 'or equivalent'.
Requirements for the delivered medical products and participants:
1. The offered medical products must comply with the requirements of the Medical Devices Act (ZMI) - this must be declared in the technical proposal of the participant;
2. The medical products must have a Declaration of Conformity for the offered medical products/Certificate or equivalent documents confirming compliance with the applicable EU Directive / Regulation (EU) 2017/745 of the European Parliament and of the Council of April 5, 2017 for medical devices, Directive 93/42 EEC or Directive 98/79 EC for in-vitro diagnostic medical products, issued by a notified body under the ZMI / or equivalent;
3. The medical product must possess a quality certificate - CE marking, in accordance with the applicable EU directive / or equivalent;
The participant declares compliance under points 2 and 3 in their technical proposal.
If a specific medical product is not required by law/directive a Declaration of Conformity and/or certificate for 'CE' marking, the participant applies a free-text declaration, in which they declare this circumstance.
The selected contractor, before signing the contract, submits a Declaration of Conformity for the offered medical products / Certificate or equivalent documents confirming compliance with the applicable EU Directive - Directive 93/42 EEC or Directive 98/79 EC for in-vitro diagnostic medical products, Regulation (EU) 2017/745 of the European Parliament and of the Council of April 5, 2017 for medical devices, issued by a notified body under the ZMI, EU certificate for the applied 'CE' marking on the product or equivalent document in accordance with the requirements of Art.8 and Art.15 of ZMI with a translation into Bulgarian.
4. The shelf life of the medical products should not be less than 6 (six) months from the date of the acceptance-protocol for their delivery;
5. The participant must submit catalogs, brochures, information sheets, or equivalent with the offered medical products, in which detailed information about them should be included with a translation also in Bulgarian, from which all indicators and production characteristics can be clearly seen, proving the quality of the offered product and its compliance with technical specifications and equipment.
6. The quantities indicated for individual specified positions are estimated and should not be interpreted as an obligation of the Contracting Authority for a minimum or maximum total quantity (within the contractual duration) of the specified medical products. If necessary, the stated quantities may be exceeded.

LOT-0008
Detergent rinse solution for FACSCanto.
№ / Name / Description / unit / Estimated quantity for 24 months
1. Detergent rinse solution for stopping the flow cytometer FACSCanto, packaging of 5 liters - package - 20
Everywhere in the Specification, where a specific model, source, process, trademark, type, origin, or production is indicated, which would lead to the advantage or elimination of certain persons or products, it should be read and understood as 'or equivalent'.
Requirements for the delivered medical products and participants:
1. The offered medical products must comply with the requirements of the Medical Devices Act (ZMI) - this must be declared in the technical proposal of the participant;
2. The medical products must have a Declaration of Conformity for the offered medical products/Certificate or equivalent documents confirming compliance with the applicable EU Directive / Regulation (EU) 2017/745 of the European Parliament and of the Council of April 5, 2017 for medical devices, Directive 93/42 EEC or Directive 98/79 EC for in-vitro diagnostic medical products, issued by a notified body under the ZMI / or equivalent;
3. The medical product must possess a quality certificate - CE marking, in accordance with the applicable EU directive / or equivalent;
The participant declares compliance under points 2 and 3 in their technical proposal.
If a specific medical product is not required by law/directive a Declaration of Conformity and/or certificate for 'CE' marking, the participant applies a free-text declaration, in which they declare this circumstance.
The selected contractor, before signing the contract, submits a Declaration of Conformity for the offered medical products / Certificate or equivalent documents confirming compliance with the applicable EU Directive - Directive 93/42 EEC or Directive 98/79 EC for in-vitro diagnostic medical products, Regulation (EU) 2017/745 of the European Parliament and of the Council of April 5, 2017 for medical devices, issued by a notified body under the ZMI, EU certificate for the applied 'CE' marking on the product or equivalent document in accordance with the requirements of Art.8 and Art.15 of ZMI with a translation into Bulgarian.
4. The shelf life of the medical products should not be less than 6 (six) months from the date of the acceptance-protocol for their delivery;
5. The participant must submit catalogs, brochures, information sheets, or equivalent with the offered medical products, in which detailed information about them should be included with a translation also in Bulgarian, from which all indicators and production characteristics can be clearly seen, proving the quality of the offered product and its compliance with technical specifications and equipment.
6. The quantities indicated for individual specified positions are estimated and should not be interpreted as an obligation of the Contracting Authority for a minimum or maximum total quantity (within the contractual duration) of the specified medical products. If necessary, the stated quantities may be exceeded.

LOT-0009
Blood-stopping consumables - sterile, resorbable, biocompatible hemostatic based on 100% oxidized cellulose, with antimicrobial effect.
№ / Name / Description / unit / Estimated quantity for 24 months
Blood-stopping consumables - sterile, resorbable, biocompatible hemostatic based on 100% oxidized cellulose, with antimicrobial effect.
1. type cloth (10 pieces in a box), dimensions-10 pcs.-7.5 cm x 5 cm - box - 1
2. type cloth (10 pieces in a box), dimensions-20 pcs - 20 cm x 10 cm - box - 2
3. fibrous multilayer (10 pieces in a box X dimensions: 5 cm x 10 cm-20 pcs - box - 2
4. fibrous multilayer (10 pieces in a box X dimensions: 10 cm x 10 cm-10 pcs - box - 4
5. fibrous multilayer (10 pieces in a box). dimensions: 2.5 cm x 5 cm - box - 1
It is mandatory that the completeness of the offer for the specified position is ensured - the participant offers all nomenclature units from the position.
Everywhere in the Specification, where a specific model, source, process, trademark, type, origin, or production is indicated, which would lead to the advantage or elimination of certain persons or products, it should be read and understood as 'or equivalent'.
Requirements for the delivered medical products and participants:
1. The offered medical products must comply with the requirements of the Medical Devices Act (ZMI) - this must be declared in the technical proposal of the participant;
2. The medical products must have a Declaration of Conformity for the offered medical products/Certificate or equivalent documents confirming compliance with the applicable EU Directive / Regulation (EU) 2017/745 of the European Parliament and of the Council of April 5, 2017 for medical devices, Directive 93/42 EEC or Directive 98/79 EC for in-vitro diagnostic medical products, issued by a notified body under the ZMI / or equivalent;
3. The medical product must possess a quality certificate - CE marking, in accordance with the applicable EU directive / or equivalent;
The participant declares compliance under points 2 and 3 in their technical proposal.
If a specific medical product is not required by law/directive a Declaration of Conformity and/or certificate for 'CE' marking, the participant applies a free-text declaration, in which they declare this circumstance.
The selected contractor, before signing the contract, submits a Declaration of Conformity for the offered medical products / Certificate or equivalent documents confirming compliance with the applicable EU Directive - Directive 93/42 EEC or Directive 98/79 EC for in-vitro diagnostic medical products, Regulation (EU) 2017/745 of the European Parliament and of the Council of April 5, 2017 for medical devices, issued by a notified body under the ZMI, EU certificate for the applied 'CE' marking on the product or equivalent document in accordance with the requirements of Art.8 and Art.15 of ZMI with a translation into Bulgarian.
4. The shelf life of the medical products should not be less than 6 (six) months from the date of the acceptance-protocol for their delivery;
5. The participant must submit catalogs, brochures, information sheets, or equivalent with the offered medical products, in which detailed information about them should be included with a translation also in Bulgarian, from which all indicators and production characteristics can be clearly seen, proving the quality of the offered product and its compliance with technical specifications and equipment.
6. The quantities indicated for individual specified positions are estimated and should not be interpreted as an obligation of the Contracting Authority for a minimum or maximum total quantity (within the contractual duration) of the specified medical products. If necessary, the stated quantities may be exceeded.

LOT-0010
Munchucks.
№       /  Name/                       Description        / measure  /Forecast quantity for 24 months

Hemostatic consumables - sterile, resorbable, biocompatible hemostatic based on 100% oxidized cellulose, with antimicrobial effect
1. Mouthpiece 60/23.5/25 for respiratory testing system, model SpiroMaster - (100 pieces per package) - package - 3
2. Mouthpiece with antibacterial filter with activated carbon 60/32/30 for diffusing system by Ganshorn - (100 pieces per package) - package - 2
3. Mouthpiece with antibacterial filter with activated carbon 60/32/30 for spirometer, model CardioSof - (100 pieces per package) - package - 2
4. Mouthpieces for Shiller apparatus/Spirometer - Micro Gard II B bacterial filters with built-in mouthpiece 28 ID mm - pieces - 900
It is mandatory that the proposal condition for completeness of the offer in the separated position – the participant offers all nomenclature units from the position.
Everywhere in the Specification, where a specific model, source, process, trademark, type, origin or production is mentioned that may lead to favoritism or exclusion of certain individuals or products, it should be read and understood as "or equivalent".
Requirements for the supplied medical devices and participants: 1. The offered medical devices must meet the requirements of the Medical Devices Act /MDA/ - declared in the technical proposal of the participant; 2. The medical devices must possess a Declaration of Conformity for the offered medical devices/Certificate or equivalent documents concerning compliance with the applicable EU Directive / Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, Directive 93/42 EEC or Directive 98/79 EC for in vitro diagnostic medical products, issued by a notified body within the meaning of the MDA /or equivalent/; 3. The medical device must have a Certificate of Quality - CE marking, according to the applicable EU directive /or equivalent/;      The participant declares compliance under points 2 and 3 in its technical proposal. In case a specific medical device is not legally required to have a Declaration of Conformity and/or a CE marking certificate, the participant submits a declaration in free text, declaring this circumstance. The selected contractor, before concluding the contract, presents a Declaration of Conformity for the offered medical devices /Certificate or equivalent documents for compliance with the applicable EU Directive - Directive 93/42 EEC or Directive 98/79 EC for in vitro diagnostic medical products, Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 for medical devices, issued by a notified body within the meaning of the MDA, an EU certificate for the applied "CE" marking on the product or an equivalent document in accordance with the requirements of articles 8 and 15 of the MDA with a translation into Bulgarian. 4. The shelf life of the medical devices should not be shorter than 6 (six) months, starting from the date of the acceptance protocol for their delivery; 5. The participant must submit catalogs, brochures, information sheets, or equivalent with the offered medical devices, which must include detailed information about them with a translation into Bulgarian, showing all indicators and manufacturing characteristics, proving the quality of the offered product and its compliance with technical specifications and equipment. 6. The indicated quantities for the separate separated positions are forecasted and should not be interpreted as an obligation of the Contracting Authority for a minimum or maximum total quantity (within the contract period) of the stated medical devices. If necessary, the requested quantities may be exceeded. 

LOT-0011
Consumables for blood gas analyzer Start profile PRIME.
№       /  Name/                       Description        / measure  /Forecast quantity for 24 months
1. Calibration package CCS COMP /300 samples / - package - 4
2. Sensor card Prime CCS COMP /200 samples/-package-12

It is mandatory that the proposal condition for completeness of the offer in the separated position – the participant offers all nomenclature units from the position. Everywhere in the Specification, where a specific model, source, process, trademark, type, origin or production is mentioned that may lead to favoritism or exclusion of certain individuals or products, it should be read and understood as "or equivalent". Requirements for the supplied medical devices and participants: 1. The offered medical devices must meet the requirements of the Medical Devices Act /MDA/ - declared in the technical proposal of the participant; 2. The medical devices must possess a Declaration of Conformity for the offered medical devices/Certificate or equivalent documents concerning compliance with the applicable EU Directive / Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, Directive 93/42 EEC or Directive 98/79 EC for in vitro diagnostic medical products, issued by a notified body within the meaning of the MDA /or equivalent/; 3. The medical device must have a Certificate of Quality - CE marking, according to the applicable EU directive /or equivalent/;      The participant declares compliance under points 2 and 3 in its technical proposal. In case a specific medical device is not legally required to have a Declaration of Conformity and/or a CE marking certificate, the participant submits a declaration in free text, declaring this circumstance. The selected contractor, before concluding the contract, presents a Declaration of Conformity for the offered medical devices /Certificate or equivalent documents for compliance with the applicable EU Directive - Directive 93/42 EEC or Directive 98/79 EC for in vitro diagnostic medical products, Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 for medical devices, issued by a notified body within the meaning of the MDA, an EU certificate for the applied "CE" marking on the product or an equivalent document in accordance with the requirements of articles 8 and 15 of the MDA with a translation into Bulgarian. 4. The shelf life of the medical devices should not be shorter than 6 (six) months, starting from the date of the acceptance protocol for their delivery; 5. The participant must submit catalogs, brochures, information sheets, or equivalent with the offered medical devices, which must include detailed information about them with a translation into Bulgarian, showing all indicators and manufacturing characteristics, proving the quality of the offered product and its compliance with technical specifications and equipment. 6. The indicated quantities for the separate separated positions are forecasted and should not be interpreted as an obligation of the Contracting Authority for a minimum or maximum total quantity (within the contract period) of the stated medical devices. If necessary, the requested quantities may be exceeded. 

LOT-0012
Tracheostomy canulas.
№       /  Name/                       Description        / measure  /Forecast quantity for 24 months
1. Tracheostomy (intubation) tube — cuffed with balloon No. 6 - pieces - 10
2. Tracheostomy (intubation) tube — cuffed with balloon No. 6.5 - pieces - 10
3. Tracheostomy (intubation) tube — cuffed with balloon No. 7 - pieces - 10
4. Set for taking tracheal aspirate - pieces - 800

It is mandatory that the proposal condition for completeness of the offer in the separated position – the participant offers all nomenclature units from the position. Everywhere in the Specification, where a specific model, source, process, trademark, type, origin or production is mentioned that may lead to favoritism or exclusion of certain individuals or products, it should be read and understood as "or equivalent". Requirements for the supplied medical devices and participants: 1. The offered medical devices must meet the requirements of the Medical Devices Act /MDA/ - declared in the technical proposal of the participant; 2. The medical devices must possess a Declaration of Conformity for the offered medical devices/Certificate or equivalent documents concerning compliance with the applicable EU Directive / Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, Directive 93/42 EEC or Directive 98/79 EC for in vitro diagnostic medical products, issued by a notified body within the meaning of the MDA /or equivalent/; 3. The medical device must have a Certificate of Quality - CE marking, according to the applicable EU directive /or equivalent/;      The participant declares compliance under points 2 and 3 in its technical proposal. In case a specific medical device is not legally required to have a Declaration of Conformity and/or a CE marking certificate, the participant submits a declaration in free text, declaring this circumstance. The selected contractor, before concluding the contract, presents a Declaration of Conformity for the offered medical devices /Certificate or equivalent documents for compliance with the applicable EU Directive - Directive 93/42 EEC or Directive 98/79 EC for in vitro diagnostic medical products, Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 for medical devices, issued by a notified body within the meaning of the MDA, an EU certificate for the applied "CE" marking on the product or an equivalent document in accordance with the requirements of articles 8 and 15 of the MDA with a translation into Bulgarian. 4. The shelf life of the medical devices should not be shorter than 6 (six) months, starting from the date of the acceptance protocol for their delivery; 5. The participant must submit catalogs, brochures, information sheets, or equivalent with the offered medical devices, which must include detailed information about them with a translation into Bulgarian, showing all indicators and manufacturing characteristics, proving the quality of the offered product and its compliance with technical specifications and equipment. 6. The indicated quantities for the separate separated positions are forecasted and should not be interpreted as an obligation of the Contracting Authority for a minimum or maximum total quantity (within the contract period) of the stated medical devices. If necessary, the requested quantities may be exceeded.

LOT-0013
Medical consumables for AcuSmar device.
№ / Name/ Description / measure /Estimated quantity for 24 months
1. Triple lumen catheters for temporary vascular access without side holes 13 Fr. Seldinger set - quantity - 150
2. Extracorporeal adsorber for blood Efferon LPS - Lipo polysaccharide (endotoxins and cytokines) - quantity - 10
3. Hemofilter with an area of 2.3 m² - number of capillaries not less than 14,400, with a blood fill volume of 133 ml; maximum TMP pressure 600 mmHg - quantity - 50
4. Hemofilter with an area of 1.9 m² - number of capillaries not less than 11,800, with a blood fill volume of 115 ml. maximum TMP pressure 600 mmHg - quantity - 100
5. Blood lines for hemofiltration and plasma exchange - quantity - 100
6. Plasma filters with area: 0.6 m² with blood fill volume of 48.5 ml, TMP pressure 100 mmHg - quantity - 25
7. Plasma filters with area: 0.7 m² with blood fill volume of 56.6 ml; TMP pressure 100 mmHg - quantity - 25
8. Electrolyte solution for hemofiltration with trisodium citrate. solution - bag of 5000ml, containing: Na - 139.9 mmol/l; K- 3.00 mmol/l; B158; Clu - 5.00 mmol/l; trisodium citrate - 13.30 mmol/l; Mg - 0.50 mmol/l; Cl - 104.00 mmol/l - bag - 200
It is mandatory for the completeness condition of the proposal by the specific lot - the participant offers all nomenclature units from the lot.
Everywhere in the Specification, where a specific model, source, process, trademark, type, origin or production is mentioned that could give an advantage or eliminate certain individuals or products, it should be read and understood as "or equivalent".
Requirements for the delivered medical devices and participants: 1. The offered medical devices must comply with the requirements of the Medical Devices Act /ZMI/ - declared in the technical proposal of the participant; 2. The medical devices must have a Declaration of Conformity for the offered medical devices/Certificate or equivalent documents for compliance with the applicable EU Directive / Regulation (EU) 2017/745 of the European Parliament and of the Council of April 5, 2017, concerning medical devices, Directive 93/42 EEC or Directive 98/79 EC concerning in vitro diagnostic medical products, issued by a notified body in accordance with ZMI /or equivalent/; 3. The medical device must have a Certificate of Quality - CE marking, according to the applicable EU directive /or equivalent/; The participant declares compliance per 2 and 3 in the technical proposal. In case the law/directive does not require a Declaration of Conformity and/or a certificate for “CE” marking for a specific medical device, the participant provides a declaration in free text, stating this fact. The selected contractor, before signing the contract, presents a Declaration of Conformity for the offered medical devices /Certificate or equivalent documents for compliance with the applicable EU Directive - Directive 93/42 EEC or Directive 98/79 EC concerning in vitro diagnostic medical products, Regulation (EU) 2017/745 of the European Parliament and of the Council of April 5, 2017, concerning medical devices, issued by a notified body under the meaning of ZMI, EU certificate for the applied “CE” marking on the device or equivalent document in accordance with the requirements of Art.8 and Art.15 of ZMI with a translation into Bulgarian. 4. The shelf life of the medical devices must be at least 6 (six) months from the date of the acceptance-transmission protocol for delivery; 5. The participant must provide catalogs, brochures, information sheets or equivalent for the offered medical devices, in which detailed information about them should be included with translation into Bulgarian, clearly showing all indicators and production characteristics, from which the quality of the offered device and its compliance with the technical specifications and equipment are indisputably demonstrated. 6. The stated quantities for individual lots are estimated and should not be interpreted as the client's obligation for a minimum or maximum total amount (during the contract's operation) of the stated medical devices. If necessary, the requested quantities may be exceeded.

LOT-0014
Specialized catheters for long-term intravenous therapy.
№ / Name/ Description / measure /Estimated quantity for 24 months
1. Partially implantable peripherally placed central venous catheter set. Suitable for short-term and long-term therapies allowing venous administration of fluids, drugs, nutritional therapies, blood sampling, and injection under high pressure up to 300 psi. The set should contain 1 piece single lumen catheter 3 Fr., length 450 mm. of radiopaque polyurethane material with reverse proximal taper and centimeter markings along the length; 1 pc. introducer; 1 pc. connector with side port (attached to the catheter); 1 pc. echogenic needle 21G; 1 pc. straight nitinol guide 40 cm.; 1 pc. peel-away micro introducer; 1 pc. MicroClave neutral connector; 1 pc. fixative dressing Grip-Lock; 1 pc. Safety scalpel; 1 pc. line; 1 pc. patient card - quantity - 10
2. Partially implantable peripherally placed central venous catheter set. Suitable for short-term and long-term therapies allowing venous administration of fluids, drugs, nutritional therapies, blood sampling, and injection under high pressure up to 300 psi. The set should contain 1 piece single lumen catheter 4 Fr., length 550 mm. of radiopaque polyurethane material with reverse proximal taper and centimeter markings along the length; 1 pc. introducer; 1 pc. connector with side port (attached to the catheter); 1 pc. echogenic needle 21G; 1 pc. straight nitinol guide 40 cm.; 1 pc. peel-away micro introducer; 1 pc. MicroClave neutral connector; 1 pc. fixative dressing Grip-Lock; 1 pc. Safety scalpel; 1 pc. line; 1 pc. patient card - quantity - 20
3. Partially implantable peripherally placed central venous catheter set. Suitable for short-term and long-term therapies allowing venous administration of fluids, drugs, nutritional therapies, blood sampling, and injection under high pressure up to 300 psi. The set should contain 1 piece single lumen catheter 5 Fr., length 550 mm. of radiopaque polyurethane material with reverse proximal taper and centimeter markings along the length; 1 pc. introducer; 1 pc. connector with side port (attached to the catheter); 1 pc. echogenic needle 21G; 1 pc. straight nitinol guide 40 cm.; 1 pc. peel-away micro introducer; 1 pc. MicroClave neutral connector; 1 pc. fixative dressing Grip-Lock; 1 pc. Safety scalpel; 1 pc. line; 1 pc. patient card - quantity - 10
4. Partially implantable peripherally placed central venous catheter set. Suitable for short-term and long-term therapies allowing venous administration of fluids, drugs, nutritional therapies, blood sampling, and injection under high pressure up to 300 psi. The set should contain 1 piece dual lumen catheter 4 Fr., length 450 mm. of radiopaque polyurethane material with reverse proximal taper and centimeter markings along the length; 1 pc. introducer; 1 pc. connector with side port (attached to the catheter); 1 pc. echogenic needle 21G; 1 pc. straight nitinol guide 40 cm.; 1 pc. peel-away micro introducer; 2 pcs. MicroClave neutral connectors; 1 pc. fixative dressing Grip-Lock; 1 pc. Safety scalpel; 1 pc. line; 1 pc. patient card - quantity - 10
5. Partially implantable peripherally placed central venous catheter set. Suitable for short-term and long-term therapies allowing venous administration of fluids, drugs, nutritional therapies, blood sampling, and injection under high pressure up to 300 psi. The set should contain 1 piece dual lumen catheter 5 Fr., length 500 mm. of radiopaque polyurethane material with reverse proximal taper and centimeter markings along the length; 1 pc. introducer; 1 pc. connector with side port (attached to the catheter); 1 pc. echogenic needle 21G; 1 pc. straight nitinol guide 40 cm.; 1 pc. peel-away micro introducer; 2 pcs. MicroClave neutral connectors; 1 pc. fixative dressing Grip-Lock; 1 pc. Safety scalpel; 1 pc. line; 1 pc. patient card - quantity - 10
6. Partially implantable peripherally placed central venous catheter set. Suitable for short-term and long-term therapies allowing venous administration of fluids, drugs, nutritional therapies, blood sampling, and injection under high pressure up to 300 psi. The set should contain 1 piece single lumen catheter 3 Fr., length 450 mm. of radiopaque polyurethane material with reverse proximal taper and centimeter markings along the length; 1 pc. introducer; 1 pc. connector with side port (attached to the catheter); 1 pc. echogenic needle 21G; 1 pc. straight nitinol guide 80 cm.; 1 pc. peel-away micro introducer; 1 pc. MicroClave neutral connector; 1 pc. fixative dressing Grip-Lock; 1 pc. Safety scalpel; 1 pc. line; 1 pc. patient card - quantity - 10
7. Partially implantable peripherally placed central venous catheter set. Suitable for short-term and long-term therapies allowing venous administration of fluids, drugs, nutritional therapies, blood sampling, and injection under high pressure up to 300 psi. The set should contain 1 piece single lumen catheter 4 Fr., length 550 mm. of radiopaque polyurethane material with reverse proximal taper and centimeter markings along the length; 1 pc. introducer; 1 pc. connector with side port (attached to the catheter); 1 pc. echogenic needle 21G; 1 pc. straight nitinol guide 80 cm.; 1 pc. peel-away micro introducer; 1 pc. MicroClave neutral connector; 1 pc. fixative dressing Grip-Lock; 1 pc. Safety scalpel; 1 pc. line; 1 pc. patient card - quantity - 10
........................
The specific lot consists of twelve nomenclature units, detailed in Appendix No. 1 - Technical specification.

LOT-0015
Consumables for operation of the Exion LC/QTRAP6500+ system, SCIEX.
№ / Name/ Description / measure /Estimated quantity for 24 months
1. Maintenance kit for nitrogen generator Peak Scientific Genius 3031 for Sciex QTRAP 6500+ - kit - 1
2. Set of two compressors for maintenance of nitrogen generator Peak Scientific Genius 3031 for Sciex QTRAP 6500+ - kit-1
3. Calibration kit for Sciex QTRAP 6500+, containing the following standard solutions of PPGs and solvents - kit - 1(Sciex Standards Chemical Kit with Low/High Concentration PPGs for calibration of Sciex QTRAP 6500+), containing:
Calibration standard solution POS PPG, 1E-5 M (10 μM) - 1 x 20 mL
Calibration standard solution POS PPG, 2E-6 M (2 μM) - 1 x 20 mL
Calibration standard solution POS PPG, 2E-7 M (0.2 μM) - 1 x 20 mL
Calibration standard solution NEG PPG, 3E-4 M (300 μM) - 1 x 20 mL
Calibration standard solution NEG PPG, 3E-5 M (30 μM) - 1 x 20 mL
Calibration standard solution Reserpine, 0.167 pmol/μL (0.167 μM) - 2 x 5 mL
Calibration standard solution Reserpine, 0.0167 pmol/μL (0.0167 μM) - 2 x 5 mL
Calibration standard solution ES TUNING MIX 1 x 4 mL
Ammonium acetate solution 7.5 M - 1 x 5ml
Cleansing solution (mixture methanol:water 50:50) - 1 x 30 ml
Diluting solvent (mixture acetonitrile:water 50:50 and 0.1% acetic acid) - 1 x 20 ml
Diluting solvent (mixture acetonitrile:water 95:5) - 1 x 20 ml
4. Consumables maintenance kit for ion source of Sciex QTRAP 6500+ - kit - 1 pc., containing:
(Essential MS ID-Heater Kit)
Heater -1 pc.
TIS electrode - 2 pcs.
Red PEEK tube (80cm)- 1 pc.
Spring -1 pc.
o-ring - 1 pc.
Fittings
5. PEEK fitting (10/32 inch x 1/16 inch) for ion source of Sciex QTRAP 6500+ - quantity- 1
6. PEEK tube, OD 1/16 inch x ID 0.0025 inch, for ion source of Sciex QTRAP 6500+ - quantity - 1
7. Tee fitting (with opening 0.25 mm), for Sciex QTRAP 6500+ - quantity - 1
8. Syringe with removable needle, type #1001, 1.0 mL, id 4.610 mm, for calibration of Sciex QTRAP 6500+ - quantity - 1
9. Kel-F needle with hub, for syringe type #1001, 1.0 mL, id 4.610 mm, for calibration of Sciex QTRAP 6500+, 6 pcs./pack. - pack - 1
10. Mineral oil for rotary vacuum pump for Sciex QTRAP 6500+, 1L (Mineral oil for rotary vane vacuum pumps), for Sciex QTRAP 6500+ - quantity - 4
11. Exhaust filter cartridge for vacuum pump MS 40 (Exhaust filter cartridge for the MS 40 roughing pump) - quantity - 2
12. Consumables maintenance kit for liquid chromatographer ExionLC AC, - kit 1 pc. containing:
(Essential ExionLC AC (XR) Complete Kit)
Needle - 1 pc.
Needle seal - 1 pc.
Degasser line filter - 1 pc.
Pump line filter - 1 pc.
High pressure valve rotor (HPV) - 1 pc.
Check valve (in) - 1 pc.
Check valve (out) - 1 pc.
Diaphragm - 1 pc.
Plunger seal - 2 pcs.
AS Plunger seal - 1 pc.
13. Antistatic wipes for cleaning ion source (Kimwipes) - pack - 1
It is mandatory for the completeness condition of the proposal by the specific lot - the participant offers all nomenclature units from the lot.
Everywhere in the Specification, where a specific model, source, process, trademark, type, origin or production is mentioned that could give an advantage or eliminate certain individuals or products, it should be read and understood as "or equivalent".

LOT-0016
Consumables for device CT MOTION XD 8000, manufactured by Ulrich Medical - Germany. №       /  Name/                       Description        / Measure  /Forecast quantity for 24 months
1. Pump hose model XD 8000 CT Motion - pieces - 300 -
2. Patient hose for injector 250 cm - pieces - 4000
​​​​​​​​​​
It is mandatory to meet the condition for the completeness of the proposal for the specified position - the participant must offer all nomenclature units from the position.
Everywhere in the Specification, where a specific model, source, process, brand, type, origin, or production is mentioned, which could lead to the advantage or elimination of certain individuals or products, it should be read and understood as 'or equivalent'.
Requirements for delivered medical devices and participants: 1. The offered medical devices must meet the requirements of the Medical Devices Act /ZMI/ - this is declared in the technical proposal of the participant; 2. The medical devices must have a Declaration of Conformity for the offered medical devices/Certificate or equivalent documents for compliance with the applicable Directive of the EU / Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, Directive 93/42 EEC or Directive 98/79 EC for in-vitro diagnostic medical products, issued by a notified body within the meaning of ZMI /or equivalent/; 3. The medical device must have a Quality Certificate - CE marking, in accordance with the applicable EU directive /or equivalent/; The participant declares compliance with points 2 and 3 in their technical proposal.
In case a specific medical device does not require a Declaration of Conformity and/or a “CE” marking certificate by law/directive, the participant shall submit a declaration in free text stating this circumstance.
The selected contractor, before concluding the contract, shall present a Declaration of Conformity for the offered medical devices /Certificate or equivalent documents for compliance with the applicable EU Directive - Directive 93/42 EEC or Directive 98/79 EC for in-vitro diagnostic medical products, Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, issued by a notified body within the meaning of ZMI, an EU certificate for the applied 'CE' marking on the product or an equivalent document in accordance with the requirements of Articles 8 and 15 of ZMI with a translation into Bulgarian. 4. The shelf life of the medical devices must not be shorter than 6 (six) months from the date of the acceptance protocol for their delivery; 5. The participant must provide catalogs, brochures, data sheets, or equivalent materials for the offered medical devices, which must contain detailed information about them with translation into Bulgarian, from which all indicators and production characteristics are visible, from which the quality of the offered device and its compliance with the technical specifications and equipment are indisputably proven.
6. The indicated quantities for the individual specified positions are forecasted and should not be interpreted as an obligation of the Contracting Authority for a minimum or maximum total quantity (within the term of the contract) of the indicated medical devices. If necessary, the stated quantities may be exceeded.