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510(k) Data Aggregation

    K Number
    K153162
    Device Name
    Hypocore
    Manufacturer
    NOVOCOR MEDICAL SYSTEMS, INC
    Date Cleared
    2016-05-24

    (204 days)

    Product Code
    NCX
    Regulation Number
    870.5900
    Why did this record match?
    Applicant Name (Manufacturer) :

    NOVOCOR MEDICAL SYSTEMS, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Hypocore™ is a single-use device intended to cool sterile saline, lactated ringers and other comparable low viscosity inert fluids during intravenous administration where clinically indicated for reduction of patient temperature.
    Device Description
    The Hypocore device is an inline chiller for IV (Intravenous) solutions that uses an endothermic reaction for cooling. The IV fluids enter the device through a Luer-lock connector on a standard IV tube, is cooled inside the device and exits through another Luerlock connector on a longer section of IV tube. During expected use, the device inlet is connected to an IV solution bag via an IV administration set, and its outlet is connected to an intravenous access port. It is powered by an internal non-rechargeable battery. The device has a handle to turn the device on and off. The entire device is disposable, single use and is provided pre-sterilized.
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