Device Dossier

Endoscopic bite block, oxygenating

Device Dossier for Endoscopic bite block, oxygenating (Endoscopic bite block, oxygenating, Class IIa, sponsor Device Technologies). ARTG record, intended…

Intended purpose

A dual-purpose device that is inserted into a patient's mouth to maintain patency during an endoscopic procedure to primarily protect the endoscope being introduced via the mouth; this is due to some patient's natural reflex to resist and bite down on the endoscope, thereby causing damage. It will also protect the tongue and teeth of the patient during the endoscopy and simultaneously provide the patient with an uninterrupted flow of oxygen (O2) during the procedure, and after the endoscopy, if necessary. It may also have a gas sample line that enables monitoring of the expired carbon dioxide (CO2) during the procedure.

TGA Public Summary