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TRANSFER SPIKE, aerosol filter 0.22µ, sterile, s.u.

https://unicat.msf.org/cat/product/45173
STD SINSTRFDS1F1

Valid Article

Former Code(s): -X SINSZBD0045 SINSZBE0079 ELAEFILS2-- SINSADMX022 SINSTRFDSVFV1
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.
A0704 - Systems for reconstitution and administration of pharmaceuticals
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.
I sterile
In Europe, medical material that fulfills the definition of a medical device according to the MDR (Medical Device Regulation) is classified into 4 classes
P
The order of this product needs to be justified and is only acceptable under certain conditions.
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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TRANSFER SPIKE, aerosol filter

Definition

A sterile device designed to transfer parenteral medications [e.g., intravenous fluids, drugs] between a first container(s) [e.g., a vial(s)] and a second container/administration line [e.g., an intravenous bag/line] in a non-powered closed system; it may also be used to compound and/or reconstitute medication for its preparation and administration.

Specifications

Technical specifications

  • air filter: 0.2 µm aerosol retentive
  • filtrating surface of +/- 250 mm²
  • fluid filter: 5 µm porosity and +/- 320 mm² filtering surface
  • integrated two-way valve = free-flow protection for inverted containers
  • standard perforator: external diameter 4.0 to 4.3 mm, length +/- 20 mm, fitting with common vials and containers
  • compatible with Luer-connections
  • allows multiple access for direct aspiration or fluid injection
  • flip cap or swabable needle-free access valve that closes automatically upon disconnection of syringe
  • dead volume: +/- 0.45 ml
  • PVC and latex free
  • sterile, for single use

Packaging & Labelling

Unit sterile packaging in peel-open pack

Instructions for use

Check leaflet of manufacturer

Dispose of the used device in the container for cytotoxic waste (biological risk, check protocol for safe disposal of waste)

MSF requirements

Vented dispensing pin for injecting and withdrawing cytotoxic drugs from vials and semi-rigid containers.

Protects health care professionals with needleless vented access to medication vial.

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