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510(k) Data Aggregation

    K Number
    K200916
    Device Name
    Patient Administration Set
    Date Cleared
    2020-09-01

    (148 days)

    Product Code
    Regulation Number
    892.1390
    Why did this record match?
    Applicant Name (Manufacturer) :

    Cyclomedica Australia Pty Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Patient Administration Set is a radionuclide rebreathing system and an accessory intended solely for use with the Technegas® Generator. It is designed for use as a conduit system to contain a radionuclide-labeled aerosol and permit respiration by the patient during a functional lung ventilation imaging diagnostic procedure.
    Device Description
    The Patient Administration Sets (PAS) consist of a flexible plastic tubing with a distal plastic connector which can be affixed to a radionuclide generator, a T-section connector with (2) one way valves which permits inhalation of the generated radionuclide gas and subsequent absorption of expelled gas during exhalation via a semipermeable microparticle filer. A mouthpiece (choice of soft silicone or hard plastic) is affixed to the proximal end of T-section connector for patient breathing.
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