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510(k) Data Aggregation

    K Number
    K053137
    Device Name
    ENDOTOOL DRUG DOSE CALCULATOR
    Manufacturer
    MD SCIENTIFIC LLC
    Date Cleared
    2006-06-14

    (217 days)

    Product Code
    NDC
    Regulation Number
    868.1890
    Why did this record match?
    Applicant Name (Manufacturer) :

    MD SCIENTIFIC LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EndoTool™ Drug Dose Calculator is a software support system designed for use by trained healthcare professionals to calculate any individual patient's optimal next dose for insulin administered intravenously to control blood glucose level for critically ill patients without inducing hypoglycemia (low blood glucose levels). EndoTool™ is for use with patients who are receiving a relative constant nutritional intake via intravenous fluids with dextrose, total parental nutrition or continuous gastro-intestinal feedings by any route of delivery.
    Device Description
    EndoTool™ Drug Dose Calculator is software that resides on a Microsoft/Intel platforms to calculate (see Section 9.2, page 20) the drug dose of insulin to control blood glucose levels for critically ill patients on continuous feeding (IV, TBN, or tube feeding).
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