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EXTENSION TUBING with stopcock 3 way, paediatric,s.u., ster.

https://unicat.msf.org/cat/product/65906
STD SINSEXTS3P-

Valid Article

Former Code(s): SINSEXTS3S-
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.
A030201 - Extensions
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)

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EXTENSION TUBING + 3-WAY STOPCOCK

Definition

Derivation accessory allowing to connect a catheter (peripheral or central) to an infusion or transfusion set. It has an additional venous access port with a valve to be manually operated.

Specifications

Quality standards

  • ISO 8536-4, 2019, edition 6, Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed
  • ISO 8536-10, 2015, edition 2, (confirmed 2021) Infusion equipment for medical use - Part 10: Accessories for fluid lines for single use with pressure infusion equipment

Technical specifications

  • TUBING
    • flexible, transparent PVC, DEHP free
    • fitted with a mobile male Luer-lock connector at one end and a 3-way stopcock at the other end
    • length: 10 - 30 cm
    • priming volume:
      • 1 - 2 ml (SINSEXT3--) or
      • < 0.6 ml (SINSEXT3P-)
  • 3-WAY STOPCOCK
    • lipid-resistant plastic (polycarbonate, etc.)
    • fitted with 2 female Luer-lock ports and one mobile male Luer-lock connector
  • Sterile, for single use

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

  • Make sure to confirm the fluid pathway!
  • Uncapped, open stopcock lumens pose a significant risk for contamination: always leave unused channels closed
  • Always disinfect the access port before connecting a syringe: use an antiseptic wipe/gauze, scrub the port creating friction for 15-30 seconds. Use different parts of the wipe/gauze. Allow to dry. Refer to the antiseptic table in the IPC guideline for the appropriate choice of antiseptic.

MSF requirements

Derivation accessory for general medical care.

Two different sizes are selected, because a low priming volume is required for neonatal care.

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