SET, BLOOD TRANSFUSION, with 200 µ filter, sterile, s.u.
STD
SINSSEBG1--
Valid Article
Account code:
60210
HS Code:
901890
Last Updated on:
22/10/2024, 12:25:26
Former
Code(s):
-X
Single use
A single-use device, also referred to as a disposable device, is intended for use on one patient during a single procedure. It is not intended to be reprocessed (i.e., cleaned and disinfected or sterilized).
A03010102 - Infusion controllers with filter (also transfusion controllers)
European Medical Device Nomenclature (EMDN) is the nomenclature of use by manufacturers when registering their medical devices in the EUDAMED database. EMDN is characterised by its alphanumeric structure that is established in a seven-level hierarchical tree.
In Europe, medical material that fulfills the definition of a medical device according to the MDR (Medical Device Regulation) is classified into 4 classes
BLOOD TRANSFUSION SET
Definition
The transfusion set is used to administer blood or blood products from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device includes tubing, a flow regulator, a drip chamber, an infusion line filter and a hollow spike to penetrate and connect the tubing to a pouch.
Synonym
Blood giving set
Specifications
Quality standards
ISO 1135-4, 2015, edition 6, Transfusion equipment for medical use - Part 4: Transfusion sets for single use, gravity feed
Technical specifications
- PERFORATOR
- with protector
- DROP-COUNTING CHAMBER
- calibrated in factory at 20 drops of water per ml, which corresponds to 15 drops of whole blood or Packed Red Blood Cells per ml
- with polyamide filter of 200 µ
- THUMB WHEEL REGULATOR
- allows to adjust infusion flow rate between 0 and the maximal value
- TUBING
- transparent PVC
- length: minimum 150 cm
- internal diameter: ± 3 mm
- DISTAL CONNECTOR
- mobile male Luer lock
- with protective sheath
- Sterile, for single use
Packaging & Labelling
Unit sterile packaging in peel-open pack
Instructions for use
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Precautions for Use
It should not be used with an infusion pump!
No medication or solution other than 0.9% NaCl should be added to blood components. If necessary, use a separate IV line.
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