1. The subject of the order is the successive delivery of disposable plastic containers intended for the collection of whole blood, preparation, storage and transfusion, broken down into the following parts of the order:
1) Part 1 — delivery of triple “up-down” container sets with ADSOL or SAGM enriching solution in the amount of 160,000 pcs ;
2) Part 2 — delivery of quadruple container sets with in-line filter to KKCz in the amount of 7,500 pcs
2. For a detailed description of the item of the order, see Annex 3 of the SWZ.
3. Minimum required expiry date — not less than 12 months from the date of delivery to the RCKiK in Szczecin (assessed under the criteria for evaluation of tenders).
3. The Contracting Authority authorises the submission of partial tenders. The Contractor may submit a bid for one or two parts of the order. The general breakdown of the subject of the contract into parts is presented by paragraph 1
Delivery of triple “up-down” container kits with ADSOL or SAGM enriching solution in the amount of 160,000 pcsThe short Opz was included in Section II.1.4.
The Contracting Authority stipulates that the indicated values of one-time container sets are estimated. The Contracting Authority shall have the right to fulfil a smaller amount of the object of the contract, with no less than 20% of the value of the contract (the price of the offer) within the given part.
The costs of delivery of the contract item to the office of the contracting operator shall be borne
The subject of the order must meet the requirements for blood containers and its components specified in the current issue of the European Pharmacopoeia at the date of submission of the single order.
The Contracting Authority indicates that the capacity in ml specified in the SWZ in parts 1 to 2 for all containers relates to the volume of the component contained in the container, rather than the actual volume of the container.
In order to confirm that the deliveries offered meet the requirements, characteristics, criteria, the contractor shall, together with the offer:
(a) notification of the device to the President of the Office of the Registration of Medicinal Products for Medical Devices and Biocidal Products (hereinafter referred to as “President of URPLWMiPB”) or notification to the President of URPLWMiPB of the introduction of the device into the territory of the Republic of Poland in accordance with Article 58 of the Law of 20 May 2010 on Medical Devices. Where the contractor is not subject to a notification/notification obligation (referred to in the previous task), the contractor's statement containing the grounds for the absence of that obligation;
(b) the current certificate of the notified body, with the complicity of which the conformity assessment procedure of the medical devices offered, if the medical device offered was mentioned in Article 29 (5) of the Law of 20 May 2010 on Medical Devices (Journal of Laws of 2020 item 186, as of late, m) ;
(c) a declaration of conformity by the manufacturer or authorised representative of the compliance of the essential requirements by the medical devices offered.
The Contracting Authority provides for the application of the procedure referred to in Article 139 (1) of the Law Pzp (the so-called 'reverse procedure') whereby the audit and evaluation of tenders will be first carried out, and the Contracting Authority qualifies the entity of the contractor whose offer has been at most. assessed, in the absence of grounds for exclusion and compliance with the conditions for participation in the proceedings.
Supply of quadruple container sets with in-line filter to KKCz in the amount of 7,500 pcsThe short Opz was included in Section II.1.4.
The Contracting Authority stipulates that the indicated values of one-time container sets are estimated. The Contracting Authority shall have the right to fulfil a smaller amount of the object of the contract, with no less than 20% of the value of the contract (the price of the offer) within the given part.
The costs of delivery of the contract item to the office of the contracting operator shall be borne
The subject of the order must meet the requirements for blood containers and its components specified in the current issue of the European Pharmacopoeia at the date of submission of the single order.
The Contracting Authority indicates that the capacity in ml specified in the SWZ in parts 1 to 2 for all containers relates to the volume of the component contained in the container, rather than the actual volume of the container.
In order to confirm that the deliveries offered meet the requirements, characteristics, criteria, the contractor shall, together with the offer:
(a) notification of the device to the President of the Office of the Registration of Medicinal Products for Medical Devices and Biocidal Products (hereinafter referred to as “President of URPLWMiPB”) or notification to the President of URPLWMiPB of the introduction of the device into the territory of the Republic of Poland in accordance with Article 58 of the Law of 20 May 2010 on Medical Devices. Where the contractor is not subject to a notification/notification obligation (referred to in the previous task), the contractor's statement containing the grounds for the absence of that obligation;
(b) the current certificate of the notified body, with the complicity of which the conformity assessment procedure of the medical devices offered, if the medical device offered was mentioned in Article 29 (5) of the Law of 20 May 2010 on Medical Devices (Journal of Laws of 2020 item 186, as of late, m) ;
(c) a declaration of conformity by the manufacturer or authorised representative of the compliance of the essential requirements by the medical devices offered.
The Contracting Authority provides for the application of the procedure referred to in Article 139 (1) of the Law Pzp (the so-called 'reverse procedure') whereby the audit and evaluation of tenders will be first carried out, and the Contracting Authority qualifies the entity of the contractor whose offer has been at most. assessed, in the absence of grounds for exclusion and compliance with the conditions for participation in the proceedings.