Device Dossier
Home CPAP unit
Device Dossier for Home CPAP unit (Home CPAP unit, Class IIa, sponsor Bird Healthcare). ARTG record, intended purpose, GMDN category — compiled by…
- GMDN category: Home CPAP unit
Intended purpose
The device is indicated for the treatment of obstructive sleep apnea (OSA) in patients weighing more than 30kg. It is intended for home and hospital use. This device should not be used for life support.