Device Dossier
CPAP/BiPAP nasal mask, reusable
Device Dossier for CPAP/BiPAP nasal mask, reusable (CPAP/BiPAP nasal mask, reusable, Class IIa, sponsor Bird Healthcare). ARTG record, intended purpose,…
- GMDN category: CPAP/BiPAP nasal mask, reusable
Intended purpose
Intended to provide a patient interface for application of positive pressure therapy. The mask is to be used as an accessory to CPAP or Bi-level positive pressure systems. It is intended for patients >2 years old and <12 years old. It is intended for single patient, multi-use in the home, hospital, or institutional environment.