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510(k) Data Aggregation

    K Number
    K101792
    Device Name
    LIV LINDE INTERGRATED VALVE-PORTABLE OXYGEN SYSTEM, MODEL M706
    Manufacturer
    LINDE GAS NORTH AMERICA LLC
    Date Cleared
    2011-03-18

    (263 days)

    Product Code
    ECX
    Regulation Number
    868.2700
    Why did this record match?
    Applicant Name (Manufacturer) :

    LINDE GAS NORTH AMERICA LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LIV is an inteqrated portable oxygen delivery system intended to provide supplemental oxygen to pediatrics and adults.. The device is MR-conditional (per ASTM standard 2503-05), and intended for use during MR imaging for MR1 systems up to 3.0T. Rx only. Compressed gas cylinders in service or in storage shall be stabilized or otherwise secured to prevent falling and rolling.
    Device Description
    The Linde Integrated Valve® ("LIV") is a portable oxygen delivery system, consisting of a fully integrated cylinder, valve, requlator, flow meter, and shock-absorbing quard. A range of userselectable flow settings is available, inclúding low flows that may be clinically appropriate for certain classes of patients. An additional DISS-1240 connection provides standard 50 psig oxygen delivery, while an optional bed hanger allows the LV to be readily attached to a bed. The LV is suitable for use in all healthcare settings including, but not limited to, hospital, outpatient, imaging center, ambulatory, and home healthcare.
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