9c886cbe-ec2e-4eb2-b1f3-169222954fccUpdatePublished32018-07-062016-12-01In Commercial DistributionB446758WM1PrimaryHIBCCB446758WM0Unit of UseHIBCCPolytech Filter758WM825021079POLYTECHNIC RESOURCES INC100Disposable bacterial/virus filter for pulmonary function testing. This filter is intended for single patient use only.falsefalsefalsefalsefalsetruefalsetruefalsefalsefalsetruefalseLabeling does not contain MRI Safety InformationtruefalseK04275800061097Pulmonary function testing filter/mouthpieceA non-sterile, portable, screening device intended to be used during pulmonary function testing to remove and retain microdroplets from patient breath to reduce contamination of the parent device; it is also intended to function as a mouthpiece to facilitate access to the patient’s respiratory tract. It is a bidirectional filter, typically in a plastic housing, with a proximal port/mouthpiece; it may have a basic mouthpiece portion capable of being attached to a separate dedicated mouthpiece. This is a single-use device.falseActiveBZGSpirometer, DiagnosticOuter Diameterfalsefalse