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510(k) Data Aggregation

    K Number
    K080527
    Device Name
    TWINGUARD WITH CAPNOGRAPH ACCESSORY
    Manufacturer
    TRAWAX PTY LIMITED
    Date Cleared
    2008-10-31

    (248 days)

    Product Code
    CCK, MNK
    Regulation Number
    868.1400
    Why did this record match?
    Applicant Name (Manufacturer) :

    TRAWAX PTY LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TwinGuard®, a nasal oxygen cannula and bite block, is used during endoscopy procedures to administer continuous oxygen to the nose and mouth. After endoscopy the bite block is removed, leaving the cannula in place during recovery, to continue delivering oxygen to the nose and mouth. In addition, the TwinGuard® contains an optional accessory which collects samples of the patient's breathing at the nose and mouth to measure CO2 with a capnograph during endoscopy procedures. It is intended for adult patients.
    Device Description
    The TwinGuard® consists of an endoscopic bite block with an oxygen nasal cannula, which are Class I devices, excmpt from premarket notification. The optional capnograph accessory, which enables continuous CO2 monitoring during cndoscopy procedures, is a Class II device.
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