TUBE, ENDOTRACHEAL, s.u. + CONN., w/o balloon, Ø 2.5 mm

STD SCTDTUED25-

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).
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.
R01030101 - Endotracheal tubes, cuffless, not reinforced
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.
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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BASIC ENDOTRACHEAL TUBE, non cuffed

Definition

The endotracheal tube is a tube that is placed in the trachea through the mouth or nose and between the vocal cords. It serves to provide oxygen and inhaled gases to the lungs and protects the lungs from contamination, such as gastric contents or blood. It secures the airway and permits manual or mechanical ventilation in anaesthesia or resuscitation procedures.

Specifications

Quality standards

ISO 5361, 2023, edition 4, Anaesthetic and respiratory equipment - Tracheal tubes and connectors

Technical specifications

Tracheal tube with open distal end and Magill-type point with oro-nasal angle of 37.5°

  • preformed tube: the curvature of the ETT is called "the Magill Curve", it is a curvature of +/- 140 mm radius, +/- 20 mm.
  • transparent PVC
  • size marked on the tube (inner diameter in mm)
  • graduated every cm
  • open distal end with atraumatic 38º bevel, open on the left
  • Murphy eye is optional
  • proximal end with standard connector, 15 mm outer Ø, for connecting to the ventilation system
  • radio-opaque line to confirm correct placement
  • uncuffed
  • Sterile, for single use

Packaging & Labelling

Sterile unit packaging: peel-off sachet.

(Cf Introduction: Packaging and labelling)

Instructions for use

Placing of an endotracheal tube should be done by skilled staff.

It requires the use of accessories (laryngoscope, Magill forceps...), as well as specific equipment for manual ventilation and tracheal suction.

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