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SAFETY IV CATHETER, retract.,16G (1,7x45mm), wings, grey

https://unicat.msf.org/cat/product/69434
STD SINSIVCSR16W1

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.
C01010102 - Peripheral i.v. catheters, 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
P
The order of this product needs to be justified and is only acceptable under certain conditions.
CT3+
Thermosensitive codes are defined for storage and transportation temperature requirements of the products.
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)
https://www.unicat.msf.org/web/image/product.template/569254/image_1920?unique=bd02965

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SAFETY IV CATHETER, retractable

Definition

A sterile, thin, flexible tube intended to be inserted into the peripheral vasculature of a patient to enable short-term (< 30 days) intravascular access. It is not intended to be advanced to the central vasculature. It includes a stylet for catheter introduction and wings for fixation. It is a retractable safety injection device reducing the risk of needle stick injuries. It may be used to administer fluids/blood or medication.

Specifications

Quality standards

  • EN ISO 10555-1, 2013, edition 3, +A1 2017 Sterile, single-use intravascular catheters - Part 1: General requirements
  • ISO 10555-5, 2013, edition 2, (confirmed 2018) Sterile, single-use intravascular catheters - Part 5: Over-needle peripheral catheter
  • 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

  • CATHETER
    • polyurethane (PUR)
    • straight and tapered distal end
    • translucent hub with standardized colour code (ISO 10555-5) and female Luer connector
    • fitted with wings (Butterfly)
  • STYLET
    • stainless steel
    • slightly longer than the cannula
    • bevelled end
    • translucent hub to observe blood reflux
    • fitted with a stopper
  • PROTECTIVE SHEATH
  • RETRACTABLE SAFETY MECHANISM
    • Needle retracts into the housing after placement of the catheter.
    • The needle is fully covered.
    • Active safety mechanism: by push button or depression of the needle housing (semi-automatic)
    • The safety mechanism remains in place once activated.
  • Sterile, for single use

Comes in 5 sizes: 16G to 24G

Caution, the colour code used to denote Gauge is different from that used for other needles.

SEE TABLE BELOW

Packaging & Labelling

Unit sterile packaging in peel-open pack

Instructions for use

Please consult the Manual of nursing Care Procedures, MSF, 2020 available online via the Nursing care working Group sharepoint page.

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Extra Tables

Colour Couleur

Gauge

External Ø

Internal Ø

length / longueur

Use / utilisation

Yellow

Jaune

24

0.74 mm

0.55 mm

19 mm

neonatology, paediatrics

néonatalogie, pédiatrie

Blue

Bleu

22

0.90 mm

0.65 mm

25 mm

infusion in veins of reduced calibre, extremities of age

perfusion dans des veines de calibre réduit, âges extrêmes

Pink

Rose

20

1.00 mm

0.75 mm

32 mm

typical infusion 

perfusion classique

Green

Vert

18

1.30 mm

0.95 mm

45 mm

transfusion

Grey

Gris

16

1.75 mm

1.35 mm

45 mm

emergency, rapid transfusion/infusion, large volumes

urgence, transfusion/perfusion rapide, gros volumes