Device Dossier
Connector, mouthpiece, single-use
Device Dossier for Connector, mouthpiece, single-use (Connector, mouthpiece, single-use, Class IIa, sponsor Emergo). ARTG record, intended purpose, GMDN…
- GMDN category: Connector, mouthpiece, single-use
Intended purpose
The breathing mouthpiece is a rigid device that is inserted into the patient’s mouth. It ensures a proper lip seal during the patient’s inline breathing. It is connected to the device for cardiopulmonary exercise testing (CPET) or pulmonary function testing (PFT). This helps the patient to allow inspiratory and expiratory maneuvers through the CPET or PFT equipment.