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    K Number
    K142291
    Device Name
    GMX Series Medical Air/Oxygen Blender
    Manufacturer
    GENTEC (SHANGHAI) CORPORATION
    Date Cleared
    2015-05-19

    (274 days)

    Product Code
    BZR
    Regulation Number
    868.5330
    Why did this record match?
    Applicant Name (Manufacturer) :

    GENTEC (SHANGHAI) CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The GMX Series Medical Air/Oxygen Blender is designed to dispense a continuous blend of Medical Air and Oxygen via outlet ports to infant, pediatric, and adult patients.
    Device Description
    The GMX Series Medical Air/Oxygen blender is a restricted medical device intended for use by qualified and trained personnel under the direction of a physician in institutional environments where delivery of air/oxygen mixtures is required. The GMX Series Medical Air/Oxygen blender includes two models: GMX30U-AIR/O2, GMX120U-AIR/O2. The GMX Series Medical Air/Oxygen blender is designed, tested, and will be manufactured in accordance with the following standard: ISO 11195 Gas mixers for medical use - Stand-alone gas mixers 1995.
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