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NASAL OXYGEN CANNULA, 2 prongs + tube, premature

https://unicat.msf.org/cat/product/18282
STD SCTDCANN2PL

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).
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.
R03010203 - Oxygen therapy nasal cannulas
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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NASAL CANNULA, OXYGEN

Definition

A non-sterile, semi-rigid tube with nasal prongs designed to be inserted into the nostrils of a patient, and held in place with an over-the-ear tubing, to administer oxygen.

Synonym

nasal prongs, over-the-ear cannula​

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
  • ISO 18190, 2016, edition 1, Anaesthetic and respiratory equipment - General requirements for airways and related equipment

Technical specifications

  • 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. Multi-channel design which permits oxygen flow even if the tubing is kinked.
  • Narrow, atraumatic (curved) prongs with lateral eyes, fixed to a flexible horizontal support
  • Over-the-ear tubing adjustable using a sliding ring
  • Y connection with oxygen tube fitted with female conical connector
  • Maximum flow/ minute (according the Ø of delivery tube)
    • premature and neonates: 1.5 - 2 l/min
    • child and adult: 6 liter/min
  • Non sterile, for single patient use
  • C​omes in 4 sizes: adult, child, neonate, premature
  • Length of the oxygen tube: ± 2 m

Packaging & Labelling

Individually packed in a sealed plastic envelope

Instructions for use

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