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NEEDLE, s.u., Luer, retractable, 21Gx38 mm, green (SafeR)

https://unicat.msf.org/cat/product/91134
STD SINSNEEDR21

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.
A0101010101 - Hypodermic syringe needles, with safety systems
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
CT3+
Thermosensitive codes are defined for storage and transportation temperature requirements of the products.
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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NEEDLE, retractable, (SafeR)

Definition

A sterile, sharp bevel-edged, hollow tubular metal device intended to be used in conjunction with syringes to administer fluids or medications to a patient.

SafeR® Sting is a retractable safety stainless steel needle, designed for use with SafeR® Syringes only.

Specifications

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Quality standards

  • ISO 7864, 2016, edition 4, (confirmed 2021) Sterile hypodermic needles for single use - Requirements and test methods
  • ISO 9626, 2016, edition 2, (confirmed 2021) Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods
  • ISO 6009, 2016, edition 4, (confirmed 2021) Hypodermic needles for single use - Colour coding for identification
  • ISO 80369-7, 2021, edition 2, Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications
  • ISO 23908, 2013, edition 1, Sharps injury protection - Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling

Technical specifications

  • NEEDLE
    • stainless steel
    • tapered bevel
    • lubricated
    • with protective sheath
  • HUB
    • polypropylene, etc.
    • female Luer connector
    • standardized colour code (ISO 6009)
  • Sterile, for single use

availble sizes:

Nominal sizeexternal Ølengthcolour
21 G0.8 mm38 mmgreen
23 G0.6 mm32 mmblue
25G0.5 mm25 mmorange

Packaging & Labelling

Unit sterile packaging in peel-open pack

To be Ordered Separately

SafeR® Syringes

Instructions for use

  • Plan safe handling and disposal before any procedure
  • Use safe and effective needle alternatives when available
  • Immediately dispose of contaminated needles in a sharps container

Precautions for Use

To prevent accidental needlestick injuries, never recap the needle after use.

Storage

Shelf life 3 years.

No special storage or transportation condition. Recommendations to store in room temperature. Store in dry and warm place and not exposed to strong light.

MSF requirements

Allows injections using devices with a sharp injury prevention (SIP), important in VHF context.

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