Device Dossier
CPAP/BiPAP nasal mask, reusable
Device Dossier for CPAP/BiPAP nasal mask, reusable (CPAP/BiPAP nasal mask, reusable, Class IIa, sponsor iJoysBio). ARTG record, intended purpose, GMDN…
- GMDN category: CPAP/BiPAP nasal mask, reusable
Intended purpose
The mask is a noninvasive 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. 1. The mask is intended for single- adult patient (weighing > 30kg/66lb) reuse in the home environment. 2. The mask is intended for single-adult patient (weighing > 30kg/66lb) use in the hospital or institutional environment.