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NEEDLE, s.u., Luer, 21 G (0.8 x 40 mm) green, IM

https://unicat.msf.org/cat/product/18670
STD SINSNEED21-

Valid Article

Former Code(s): -X
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.
A0101010102 - Hypodermic syringe needles, w/o 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, Luer

Definition

A sterile, sharp bevel-edged, hollow tubular metal device intended to be used in conjunction with syringes or giving sets to prepare and administer fluids/medications/drugs to a patient and/or to withdraw (aspirate) fluids from a patient.

Specifications

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

Technical specifications

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

Exists in 5 sizes: the Ø is defined by the different ISO standards (including the color code), the length is manufacturer dependent.

Gaugenominal outer diameterlength +/- 10%colour
19 G1.1 mm40 mmcream
21 G0.8 mm40 mmgreen
23 G0.6 mm30 mmblue
25G0.5 mm25 mmorange
26 G0.45 mm13 mmbrown

Packaging & Labelling

Unit sterile packaging in peel-open pack

Instructions for use

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Precautions for Use

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

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