Device Dossier

Pulmonary function testing filter/mouthpiece

Device Dossier for Pulmonary function testing filter/mouthpiece (Pulmonary function testing filter/mouthpiece, Class IIa, sponsor Innervate). ARTG…

Intended purpose

The EasyOne FlowTube and EasyOne Spirette are dedicated Mouthpieces designed specifically for EasyOne Spirometers and EasyOne Pulmonary Function Testing Devices. The EasyOne FlowTube and the EasyOne Spirette contain Bacterial and Viral Filter Membranes which have been tested by independent laboratories and are proven to protect the EasyOne range of Spirometers from cross-contamination. The EasyOne FlowTube and EasyOne Spirette are single-patient use.

TGA Public Summary