Device Dossier
Home BPAP unit
Device Dossier for Home BPAP unit (Home BPAP unit, Class IIa, sponsor Taevas Life Sciences). ARTG record, intended purpose, GMDN category — compiled by…
- GMDN category: Home BPAP unit
- Sponsor: Taevas Life Sciences
Intended purpose
Positive Airway Pressure Units are indicated for the treatment of Obstructive Sleep Apnea (OSA) in adult patients weighing more than 66 lb (30 kg). They are intended for home and hospital/institutional use.