Device Dossier
CPAP/BiPAP face mask, reusable
Device Dossier for CPAP/BiPAP face mask, reusable (CPAP/BiPAP face mask, reusable, Class IIa, sponsor Wiselink Group). ARTG record, intended purpose,…
- GMDN category: CPAP/BiPAP face mask, reusable
Intended purpose
The CPAP mask channels airflow noninvasively to patient from a positive airway pressure (PAP) device such as a continuous positive airway pressure (CPAP) or Bi-level system. The CPAP mask is to be used by patients (weighting>30kg) for whom positive airway pressure therapy has been prescribed and intended for single-patient reuse in the home environment and multi-patient reuse in the hospital/institutional environment.