Device Dossier

Basic endotracheal tube, single-use

Device Dossier for Basic endotracheal tube, single-use (Basic endotracheal tube, single-use, Class IIa, sponsor Koala Medical). ARTG record, intended…

Intended purpose

A hollow cylinder inserted orally or nasally into the trachea to provide an unobstructed airway to convey gases and vapours to and from the lungs during anaesthesia, resuscitation, and other situations where the patient is not properly ventilated. This device is packaged with a connector that will attach to a breathing circuit or manual resuscitator, has a distal inflatable cuff to seal against the tracheal wall, is radiopaque and has a built-in pilot balloon for cuff pressure monitoring. It is made of plastic they are available in various diameters and lengths for adult and paediatric patients. This is a single-use device.

TGA Public Summary