Device Dossier

CPAP/BiPAP nasal mask, single-use

Device Dossier for CPAP/BiPAP nasal mask, single-use (CPAP/BiPAP nasal mask, single-use, Class IIb, sponsor Obex MedTech). ARTG record, intended purpose,…

Intended purpose

AirLife Vented and Non-Vented Full Face Mask is a patient interface for use as an accessory to a respiratory therapy device, i.e. ventilator that has adequate alarms and safety systems for ventilator failure, providing noninvasive positive pressure respiratory therapy. The mask is for single patient use with spontaneously breathing adult (>30 kg) patients with respiratory insufficiency or respiratory failure who are suitable for noninvasive pressure support ventilation in hospital and institutional environments.

TGA Public Summary