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SAFETY IV CATHETER, tip,16G x 45 mm, wings, IP, grey

https://unicat.msf.org/cat/product/69439
STD SINSIVCST16W1

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.
C0101010201 - Peripheral i.v. catheters, with safety systems, with injection valve
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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SAFETY IV CATHETER, tip shield

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, an injection port and wings for fixation.

It is a safety injection device reducing the risk of needle stick injuries. It may be used to administer fluids/blood or medication.

Specifications

Image

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) is the first choice material, FEP is the second choice option.
    • straight and tapered distal end
    • translucent hub with standardized colour code (ISO 10555-5) and female Luer connector
    • fitted with wings (Butterfly)
    • with injection port
  • STYLET
    • stainless steel
    • slightly longer than the cannula
    • bevelled end
    • translucent hub (flashback chamber) to observe blood reflux
    • fitted with a stopper (flashplug)
  • PROTECTIVE SHEATH
  • SAFETY MECHANISM
    • While retracting the stylet from the catheter, a device is placed upon the tip of the stylet (shape of tip is brand specific, see picture)
    • Passif safety mechanism: the user does not have to activate the safety mechanism.
    • The safety tip protection remains in place once activated.
  • Sterile, for single use

Comes in 6 sizes: 14G 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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MSF requirements

IV catheter with passive safety mechanism for general use.

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Extra Tables

Colour / Couleur

Gauge

External Ø

Internal Ø

length / longueur

flow rate

ml/min

Use / utilisation

Yellow

Jaune

24

0.74 mm

0.55 mm

19 mm

23

neonatology, paediatrics

néonatalogie, pédiatrie

Blue

Bleu

22

0.90 mm

0.65 mm

25 mm

36

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

60

typical infusion / perfusion classique

Green

Vert

18

1.30 mm

0.95 mm

45 mm

95

transfusion

Grey

Gris

16

1.75 mm

1.35 mm

45 mm

200

emergency, fluid resuscitation requires at least 16 G cannula

urgence, la réanimation liquidienne nécessite au moins une canule de 16 G

Orange

142.1 mm1.6045 mm305

emergency, rapid transfusion/infusion, large volumes

urgence, transfusion/perfusion rapide, gros volumes