Device Dossier
CPAP/BiPAP nasal mask, reusable
Device Dossier for CPAP/BiPAP nasal mask, reusable (CPAP/BiPAP nasal mask, reusable, Class IIa, sponsor Emergo). ARTG record, intended purpose, GMDN…
- GMDN category: CPAP/BiPAP nasal mask, reusable
Intended purpose
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: To be used by adult patients (greater than 66 lb / 30 kg) for whom positive airway pressure therapy has been prescribed and intended for single-patient re-use in the home environment and multi-patient re-use in the hospital/institutional environment.