Device Dossier
CPAP/BiPAP face mask, reusable
Device Dossier for CPAP/BiPAP face mask, reusable (CPAP/BiPAP face mask, reusable, Class IIa, sponsor Fisher & Paykel Healthcare). ARTG record, intended…
- GMDN category: CPAP/BiPAP face mask, reusable
Intended purpose
The NIV Full Face Mask is intended to be used by individuals who have been prescribed Non-Invasive Ventilation treatment or diagnosed by a physician as requiring CPAP or Bi-Level Ventilator treatment. The NIV Full Face Mask is intended for Single Patient Adult Use in the home and Multiple Patient Adult Use in the hospital or other clinical setting.