Supply of plasma collection kits compatible with the Aurora separator with ACDA anticoagulation fluid and isotonic physiological solution NaCl 0.9 % in bags.
Plasma collection kits, compatible with your Aurora separator with ACDA anticoagulation fluid1. Compatible with existing Aurora separator devices, disposable plasma collection kits for automatic plasma chaperesis together with plasma collection containers, needles and anticoagulant fluids (disjogator sets).
2. Sterile joining of the elements of the set.
3. Disposable, sterile and pyrogenic products.
4. Sets equipped with ports enabling sterile connection of ACD-A and NaCl fluids.
5. The unit packet label of the relevant separation set shall contain the CE mark, the name and address of the manufacturer, the ref part number in letter-digit form, the LOT series number in letter-digit form and the bar code in GS1-128 format (being EAN code 128), the expiry date in letter-digit form and the bar code in GS1-128 format (EAN 128).
6. Needle:
1) diameter 16G,
2) subjected to a treatment that increases slippage,
3) equipped with movable plastic wings, allowing to stably grasp the needle, mounted just behind the cannula,
4) secured with a closed cover – removing the cover without using any tools,
5) there is an additional cap on the drain to protect the needle after collection and ensure its irreversible blockage after donation,
6) needle drain length approx. 30 cm,
7) drain equipped with a plastic latch that allows quick closing of the needle light,
8) drain terminated with a Luer connector, allowing to disconnect and replace the needle during the procedure,
9) Luer connector equipped with a plastic screw-in cover,
7. Collection containers for plasma collection and storage:
1. each container enclosed in an individual protective package ensuring adequate humidity during storage,
2) individual containers packed in damage-resistant collective packaging,
3. the multipack contains sets of only one batch,
4. the packaging must contain information on the manufacturer's recommendations as to storage conditions,
5) containers with a nominal volume of 1000 ml made of polyvinyl chloride with the addition of an appropriate plasticizer, enabling freezing of plasma at -60°C and storage at -25°C,
6) has a permanently fixed label that is not damaged or peeled off during preparation and storage,
7) the label has dimensions that allow the main label to be glued on it in accordance with the requirements of the ISBT,
8) the label of the receiving container has a CE mark, contains the name of the manufacturer, ref part number and LOT batch number in letter-digit form and bar codes in the ISBT 128 standard,
9) the label of the unit packaging of the receiving container has a CE mark, contains the name and address of the manufacturer, contains the catalog number REF and lot series number in letter-digit form and a bar code in the format GS1-128 (which is the EAN code 128),
10) drain length approx. 22 cm
8. Anticoagulant fluid:
1. each container enclosed in an individual protective package ensuring adequate humidity during storage,
2) individual containers packed in damage-resistant collective packaging,
3. the multipack contains sets of only one batch,
4. the packaging must contain information on the manufacturer's recommendations as to storage conditions,
5) the container must have a minimum of one port to connect the set to the apheresis,
6) the container must be able to be hung on a stand,
7. the material from which the containers are made must be transparent, allowing a visual assessment of the liquids contained in the containers,
8) it must be disposable, apirogenic, non-toxic, for intravenous administration during apheresis procedures,
9) a volume of liquid 500 ml,
10. the marking of the container must contain the following information: manufacturer's name, capacity, name and composition of the liquid, reference number and LOT number, expiry date of the container, CE marking. The marking must be in red, allowing the container to be identified at each stage of use (safety of liquid connection),
Isotonic physiological solution NaCl 0,9 % in bags1. Each container enclosed in an individual safety package ensuring adequate humidity during storage.
2. Individual containers packed in damage-resistant collective packaging.
3. The multipack contains sets of only one batch.
4. The packaging must bear information on the manufacturer's recommendations as to storage conditions.
5. The container must have a minimum of one port to connect the set to the apheresis,
6. The container must be capable of being hung on a stand.
7. The material of which the containers are made must be transparent and capable of visually assessing the liquids contained in the containers.
8. It must be disposable, apirogenic, non-toxic, for intravenous administration during apheresis procedures,
9. Volume of liquid 500 ml,
10. The labelling of the container must contain the following information: manufacturer's name, capacity, name and composition of the liquid, reference number and LOT number, expiry date of the container, marking.