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…
- GMDN category: Pulmonary function testing filter/mouthpiece
Intended purpose
A non-sterile bacterial/viral filter intended to be used during pulmonary function testing to remove and retain microdroplets from patient breath to prevent contamination of the parent device and the immediate environment. It is also intended to function as a mouthpiece to facilitate access to the patient's respiratory tract. It may have a basic mouthpiece portion capable of being attached to a separate dedicated mouthpiece. This is a single patient-use device.