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510(k) Data Aggregation

    K Number
    K103801
    Device Name
    HYPOTHERMX INTRAVENOUS FLUID WARMER
    Manufacturer
    EMIT CORPORATION
    Date Cleared
    2011-05-20

    (143 days)

    Product Code
    LGZ
    Regulation Number
    880.5725
    Why did this record match?
    Applicant Name (Manufacturer) :

    EMIT CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The HypothermX® is intended to warm blood, blood products and intravenous solutions prior to administration. The HypothermX® is intended to be used by healthcare professionals in clinical and field environments.
    Device Description
    The HypothermX® Intravenous Fluid and Blood Warmer consists of a single unit that is placed between a standard IV infusion set and a standard IV extension set. HypothermX® is designed to warm blood, blood products and intravenous fluids at flow rates of up to and including 50-200 ml/min. HypothermXo will deliver temperatures of 38°C-3°C. HypothermX's® fluid path is sterile and the entire warming unit is disposable after use. HypothermXo is battery operated. Blood, blood products and intravenous fluids travel through the sterile tubing and are heated by flameless catalytic combustion. The temperature of the device is accurately controlled by the device's electronics.
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