Device Dossier

CPAP/BiPAP face mask, single-use

Device Dossier for CPAP/BiPAP face mask, single-use (CPAP/BiPAP face mask, single-use, Class IIa, sponsor Intersurgical). ARTG record, intended purpose,…

Intended purpose

A flexible, form-shaped device designed to be placed over a user's nose and mouth to interface with a continuous positive airway pressure (CPAP) or bi-level positive airway pressure (BiPAP) unit to provide the respiratory tract with direct ambient air, or medical oxygen (O2) and air, at a higher pressure than ambient air for noninvasive positive pressure ventilation (NPPV). Creates a seal around the nose and mouth. It is available in various designs and sizes and stabilized with a headstrap.

TGA Public Summary