Device Dossier
CPAP system with Mask - Home CPAP unit
Device Dossier for CPAP system with Mask - Home CPAP unit (Home CPAP unit, Class IIa, sponsor Plus Medical). ARTG record, intended purpose, GMDN category…
- GMDN category: Home CPAP unit
Intended purpose
This system consists of a CPAP unit, CPAP masks that are compatible with the machine, and a pack of wipe for cleaning the masks. It is intended to improve the quality of sleep for individuals by delivering positive airway pressure. It is intended for the treatment of Obstructive Sleep Apnea (OSA) in patients weighing over 66 lb (30 kg). It is intended for home and hospital/institutional use. Manufacturer Details Address Certifi