Device Dossier
CPAP/BiPAP face mask, reusable
Device Dossier for CPAP/BiPAP face mask, reusable (CPAP/BiPAP face mask, reusable, Class IIa, sponsor Boian Surgical). ARTG record, intended purpose,…
- GMDN category: CPAP/BiPAP face mask, reusable
Intended purpose
A facial mask intended to be placed over a patient's mouth and nose to provide a comfortable interface between the patient and ventilator for the intake of air. The mask is for single patient use in the home or multiple patient use in the clinical setting and intended for use by individuals diagnosed as requiring CPAP or Bi-Level Ventilator treatment.