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IV CATHETER, injection port, s.u. 26 G (0.6 x 19 mm) violet

https://unicat.msf.org/cat/product/65480
STD SINSIVPP26-

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).
Article is intended to be used with children (<12 years) ONLY.
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.
C0101010101 - Peripheral i.v. catheters, w/o safety systems, with injection valves
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.
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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IV CATHETER, injection port, 26 G

The IV catheters for all other sizes (14G – 24G) have been replaced by safety IV catheters : retractable (SINSIVCSR+++) ones for high risk contexts such as haemorrhagic fever and tip shielded ones (SINSIVCST+++) for all other contexts.

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 dedicated accessories to facilitate catheter introduction/placement and function: injection port, stylet and wings for fixation. It may be used to administer fluids 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

Technical specifications

  • CATHETER
    • polyurethane (PUR) or FEP
    • straight and tapered distal end
    • translucent hub with standardized colour code (ISO 10555-5) and female Luer connector
    • fitted with wings (Butterfly)
    • fitted with an injection port
  • STYLET
    • stainless steel
    • slightly longer than the cannula
    • bevelled end
    • translucent hub to observe blood reflux
    • fitted with a stopper
  • PROTECTIVE SHEATH
  • Sterile, for single use

Colour code

Gauge

External Ø (mm)

Internal Ø (mm)

Catheter length (mm)

Flow rate (ml/min)

violet

26

0.64

0.45

19

19

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

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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Precautions for Use

Ensure that the baby is warm when placing an IV line: if the baby is cold, the risk of vein rupture during the canalization is higher.

Be carefull with the use of a tourniquet: not too long and not too tight as this may also increase the risk of vein rupture. Option: ask the assistance of another colleague that uses her/his hand as tourniquet, so the pressure applied is much more controlled.

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