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ENDOTRACHEAL TUBE INTRODUCER, sterile, s.u., CH10, 70 cm

https://unicat.msf.org/cat/product/73866
STD SCTDINTAB10

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.
R018004 - Intubation device guides
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.
I sterile
In Europe, medical material that fulfills the definition of a medical device according to the MDR (Medical Device Regulation) is classified into 4 classes
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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ENDOTRACHEAL TUBE INTRODUCER

Definition

A device designed to help with the insertion of an endotracheal (ET) tube into the airways of a patient during intubation. It is a long, thin, rod-like device, angled at the distal end, designed to facilitate tracheal intubation when a poor view of the larynx is encountered during direct laryngoscopy (they can be inserted in a blind technique which is the main added value and not necessarily the directional control although also useful).

They are made with gum or polyethylene and are often called “gum elastic bougie” or GEM.

Synonym

gum elastic bougie, Eschmann or Macintosh bougie

Specifications

Technical specifications

  • Firm but elastic
  • Distal end is curved over the last centimetres (hockey stick end)
  • Length: varies according the manufacturer: 70 cm is the most common length
  • Outer diameter: available in 3 sizes:
    • 2.0 mm (CH6)
    • 3.3 mm (CH10)
    • 5.0 mm (CH15)
    • Small variations are possible
  • Sterile, for single use

Packaging & Labelling

Unit sterile packaging

(Cf Introduction: Packaging and labelling)

Instructions for use

Intended for endotracheal tubes for adults or children depending the diameter.

It is recommended to lubricate the bougie before use.

Storage

Avoid storing the bougie at extreme temperatures, as well as any contact with solvents, oil or grease which could alter the external coating.

MSF requirements

Semi-rigid bougie used to guide the endotracheal tube in difficult endo-tracheal intubations.

Particularly indicated when the glottis cannot be visualized or when anatomic obstacles hinder the introduction of a endotracheal tube.

Device reserved for staff which is trained to use it.

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