Device Dossier
CPAP/BiPAP nasal mask, reusable
Device Dossier for CPAP/BiPAP nasal mask, reusable (CPAP/BiPAP nasal mask, reusable, Class IIa, sponsor Draeger). ARTG record, intended purpose, GMDN…
- GMDN category: CPAP/BiPAP nasal mask, reusable
Intended purpose
The Mini Me Paediatric Nasal Non-Vented Mask is intended to provide an interface for application of positive pressure therapy. The mask is to be used as an accessory to CPAP or Bi-level positive pressure systems containing exhalation valves. It is intended for patients >2 years old and <12 years old.