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    K Number
    K062644
    Device Name
    FLEXWARMER, MODELS KZ-1 AND KZ-2
    Manufacturer
    MERLYN ASSOCIATES, INC.
    Date Cleared
    2007-09-11

    (370 days)

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

    MERLYN ASSOCIATES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The portable infusion warmer, FLEXWARMER KZ-1 and KZ-2 is dry warmer which supplies external heat to the plastic tubing incorporated administration sets for intermittent use and low flow rate application at 1 to 8 mL/min. The KZ-1 and KZ-2 is available in two sizes: 4mm and 5mm channels for administration sels.
    Device Description
    The portable infusion warmer, FLEXWARMER KZ-1 and KZ-2 is dry warmer which supplies external heat to the plastic tubing incorporated administration sets for intermittent use and low flow rate application at 1 to 8 mL/min. The KZ-1 and KZ-2 is available in two sizes: 4mm and 5mm channels for administration sels.
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