Device Dossier

Portable oxygen concentrator

Device Dossier for Portable oxygen concentrator (Portable oxygen concentrator, Class IIa, sponsor Cigweld). ARTG record, intended purpose, GMDN category…

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.

TGA Public Summary