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OXYGEN FACE MASK, simple, with tubing, adult size

https://unicat.msf.org/cat/product/18323
STD SCTDMASO1A-

Valid Article

Former Code(s): -X
Single patient multiple 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.
R03010201 - Air/oxygen masks
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
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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OXYGEN FACE MASK, simple

Definition

A flexible, form-shaped device designed to be placed over the nose and mouth to deliver a proportional mixture of air/oxygen to a patient's airway. It is a soft, flexible mask with an airtight seal against the patient's face. The device includes a headstrap and tubing.

Specifications

Quality standards

  • EN 13544-2, 2002, +A1 2009 Respiratory therapy equipment. Tubing and connectors
  • ISO 15001, 2010, edition 2, (confirmed 2022) Anaesthetic and respiratory equipment — Compatibility with oxygen

Technical specifications

Mask:

  • flexible transparent plastic (PVC or EVA)
  • tinted or colourless
  • lateral vent holes on both sides of the mask (simple or multiperforated openings), they enable air inflow and outflow of exhaled gases.
  • adjustable nose clip
  • conical adaptor for connecting to the tube
  • elastic fastening strap (latex-free)

Oxygen tube:

  • PVC low resistance tubing, round shape section, designed for low-flow procedures (0-15l/min)
  • Tubing compatibility with standard oxygen connecting tubing, 3-5mm internal diameter and 7-8mm external diameter, and 15/22 mm diameter ventilation tubing.
  • length: 150 to 200 cm
  • female conical connector at each end
  • can be disconnected from the mask to allow a quick shift of the tubing from the mask to the resuscitator

Non sterile, for single patient use

Packaging & Labelling

Unit packaging

Instructions for use

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