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SET, BLOOD TRANSFUSION, with 200 µ filter, sterile, s.u.

https://unicat.msf.org/cat/product/18700
STD SINSSEBG1--

Valid Article

The product is supplied (and stored) sterile, it must remain sterile until its use. Sterile = state of being free from all living microorganisms.
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).
CE marking: declaration that the product meets EU standards for health, safety, and environmental protection. The CE marking indicates that the product may be sold freely in any part of the European Economic Area, regardless of its country of origin.
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.
IIa
In Europe, medical material that fulfills the definition of a medical device according to the MDR (Medical Device Regulation) is classified into 4 classes
The product is part of at least one Kit. A kit is a collection of products (medical and/or logistic) that are needed for a certain intervention in emergency. The choice and quantity of the articles reflects the MSF protocols for this specific situation. The use of Kits allows to start an intervention without a detailed evaluation.
OC subscriptions: included in supply or field order tools (e.g. UniField)
SC subscriptions: included in supply or field tools
OC validations: approved for procurement and use by an OC for international or local orders specifying context and activity in Medical Standard Lists (MSL)

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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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