Device Dossier
CPAP/BiPAP face mask, reusable
Device Dossier for CPAP/BiPAP face mask, reusable (CPAP/BiPAP face mask, reusable, Class IIa, sponsor Emergo). ARTG record, intended purpose, GMDN…
- GMDN category: CPAP/BiPAP face mask, reusable
Intended purpose
The Full Face Mask channels airflow non-invasively to a patient from a positive airway pressure device such as a continuous positive airway pressure (CPAP) or bi-level system. The Full Face Mask is: • to be used by adult patients (greater than 66 lb / 30 kg) for whom positive airway pressure therapy has been prescribed. • intended for single-patient re-use in the home environment and multi-patient re-use in the hospital / institutional environment.