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MANIFOLD, 3 stopcocks, Luer, ster., s.u.

https://unicat.msf.org/cat/product/82393
STD SINSILMF3--

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.
A0703 - Stopcocks
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
M
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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MANIFOLD

Definition

A sterile, noninvasive device intended to provide multiple connections to an infusion fluid path. It consists of a straight-through infusion path with appropriate connectors at each end having multiple stopcock-controlled alternative connections to allow the injection/infusion of multiple different fluids/drugs. This is a single-use device.

Specifications

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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

Manifold with stopcocks: a single device with 3 integrated stopcocks assembled together in a straight line. Each stopcock has the same internal design, although the handles may be different colours.

  • Body material : polycarbonate, lipido-resistant, transparent (allows detection of air) non-PVC and non-DEHP
  • Can withstand the pressure up to 2 bar
  • Small dead space (+/- 0.75 ml)
  • Large bore, high flow
  • Luer connections: one male and one female
  • Handle: easy to grip and smooth to turn
  • ON or OFF handle design (“off” handle to indicate the direction of flow that is closed, “on” handle to indicate the openflow directions)
  • Color coding of the ports is optional
  • Protection caps at both ends and on the stopcock ports
  • Sterile, for single use

Packaging & Labelling

Unit sterile packaging in peel-open pack

Box of 25 or 100 units

Instructions for use

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Precautions for Use

  • Make sure to confirm the fluid pathway!
  • Because fluids flow through the same channel, a manifold system may not be appropriate for infusing incompatible solutions.
  • 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 stopper/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.
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