Device Dossier

Basic endotracheal tube, single-use

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

Intended purpose

To be 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. To help ensure patency of the upper airway, allow mechanical positive pressure management, protect the airway from gastric contents and permit tracheobronchial suction. The device may: 1) be packaged with a connector that will attach to a breathing circuit or manual resuscitator; 2) have a distal inflatable cuff to seal against the tracheal wall; 3) be radiopaque; and 4) have a built-in pilot balloon for cuff pressure monitoring.

TGA Public Summary