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,…
- GMDN category: CPAP/BiPAP face mask, single-use
Intended purpose
CPAP Face Masks are designed to provide the interface for CPAP or BiLEVEL to patient. This Masks is to be used as an accessory to ventilators equipped with proper alarms and safety systems for ventilator failure which is intended to monitor CPAP or positive pressure ventilation for treatment of respiratory failure, respiratory insufficiency, or obstructive sleep apnea.