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510(k) Data Aggregation

    K Number
    K070844
    Device Name
    NILIMEDIX ADI
    Manufacturer
    Date Cleared
    2008-06-06

    (437 days)

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

    NILIMEDIX LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The NiliMedix ADI insulin pump is intended for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin.
    Device Description
    The NiliMedix ADI Insulin Pump is an ambulatory, battery operated, rate programmable micro infusion pump, designed for continuous delivery of insulin. A custom reservoir is driven by the insulin pressure to deliver preset basal profiles and patient programmed bolus of insulin through FDA cleared infusion sets into subcutaneous tissue. The ADI pump is restricted to sale by, or on the order of a physician.
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