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DISPENSING SPIKE, non-vented, 2-W valve+ needleless-connect.

https://unicat.msf.org/cat/product/69635
STD SINSTRFDS2-

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.
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
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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DISPENSING SPIKE with needleless connector

Definition

A sterile device designed to transfer medical fluids (e.g., drugs and solutions) between a flexible or semi-rigid container / pouch and a syringe via a needleless connector.

Specifications

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Technical specifications

  • Non vented dispensing pin
  • Self-sealing valve system: 2-way valve to prevent leakage especially with hanging containers
  • Needle-less injection port
    • Luer activated (Luer slip compatible)
    • straight fluid pathway
    • easy to disinfect
  • Large lumen allowing high fluid flow rate
  • Sharp piercing spike permits easy penetration of rubber stopped vials and fluid containers
  • With protective cap
  • Sterile, for single use

Packaging & Labelling

Unit sterile packaging in peel-open pack

Instructions for use

Precautions for Use

Single use only: 1 fluid bag = 1 spike

Needle-less connector has to be disinfected with the alcoholic solution of chlorhexidine 2% before accessing it.

MSF requirements

A spike to allow repeated access to IV-bags and fluid bottles: Dispensing water for injection, electrolyte solutions etc.

The non-vented dispensing pin is the best adapted to the MSF standard IV fluid bags.

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