Device Dossier
Portable oxygen concentrator
Device Dossier for Portable oxygen concentrator (Portable oxygen concentrator, Class IIa, sponsor Cigweld). ARTG record, intended purpose, GMDN category…
- GMDN category: Portable oxygen concentrator
Intended purpose
To provide concentrated oxygen to patients requiring supplemental oxygen. The device is portable, enabling treatment in home, institutional, or travel environment, according to a doctor’s prescription or direction. It is not intended for use in life-supporting or life-sustaining situations and is provided non-sterile. It is designed to be used indoors or outdoors.