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,…
- GMDN category: CPAP/BiPAP nasal mask, single-use
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.