Device Dossier
CPAP/BiPAP nasal mask, reusable
Device Dossier for CPAP/BiPAP nasal mask, reusable (CPAP/BiPAP nasal mask, reusable, Class IIa, sponsor Taevas Life Sciences). ARTG record, intended…
- GMDN category: CPAP/BiPAP nasal mask, reusable
- Sponsor: Taevas Life Sciences
Intended purpose
The mask is a non-invasive accessory used for channeling airflow (With or without supplemental oxygen) to a patient from a positive airway pressure (PAP) device such as a continuous positive airway pressure (CPAP) or bi-level system. - The mask is intended for single- adult patient(weighing ＞ 30kg/66lb) reuse in the home environment. - The mask is intended for single- adult patient(weighing＞30kg/66lb) reuse in the hospital or institutional environment.