Device Dossier

CPAP/BiPAP face mask, reusable

Device Dossier for CPAP/BiPAP face mask, reusable (CPAP/BiPAP face mask, reusable, Class IIa, sponsor Breas Medical). ARTG record, intended purpose, GMDN…

Intended purpose

The Apto F01 full face mask is intended for adults weighing >30kg (66lbs) who have been prescribed PAP or Bi-level therapy. The masks are intended for single patient use in the home and/or multi-patient use in the hospital or other clinical setting where proper disinfection of the device can occur between patient uses.