Device Category Dossier

CPAP/BiPAP face mask, single-use

Device Category Dossier for CPAP/BiPAP face mask, single-use. Australian ARTG records, sponsors, device class — compiled by arcimedes.

Positive airway pressure face masks are non-sterile, single-patient devices that create an airtight seal over the nose and mouth and interface with continuous positive airway pressure (CPAP) or bi-level positive airway pressure (BiPAP) units to deliver noninvasive positive pressure ventilation. These masks are used as accessories to ventilators for monitoring and treating respiratory failure, respiratory insufficiency, and obstructive sleep apnea.