Device Dossier
Stationary oxygen concentrator
Device Dossier for Stationary oxygen concentrator (Stationary oxygen concentrator, Class IIb, sponsor iJoysBio). ARTG record, intended purpose, GMDN…
- GMDN category: Stationary oxygen concentrator
Intended purpose
This oxygen concentrator is intended for individual use as an oxygen supplement device in the professional healthcare facility and home healthcare environment. It provides high concentration of oxygen to persons requiring oxygen therapy. This device is to be used as an oxygen supplement and is NOT considered life-supporting or life-sustaining.