EXTENSION TUBING with stopcock 3 way, s.u., sterile
STD
SINSEXTS3--
Valid Article
Account code:
60210
HS Code:
901890
Last Updated on:
02/09/2024, 22:07:40
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).
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.
In Europe, medical material that fulfills the definition of a medical device according to the MDR (Medical Device Regulation) is classified into 4 classes
Thermosensitive codes are defined for storage and transportation temperature requirements of the products.
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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