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    K Number
    K040848
    Device Name
    EZ SMART
    Manufacturer
    VIP INTERNATIONAL WHOLESALERS, CORP.
    Date Cleared
    2004-08-11

    (132 days)

    Product Code
    NBW, CGA
    Regulation Number
    862.1345
    Why did this record match?
    Applicant Name (Manufacturer) :

    VIP INTERNATIONAL WHOLESALERS, CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EZ Smart Blood Glucose Test Strips are uses with the EZ Smart Meter to measure Glucose (sugar) in whole blood. The EZ Smart Test strips are for testing outside the body (in vitro diagnostic use ). The EZ Smart Blood Glucose Monitoring System is intended for use in the home and in the professional settings to monitor blood glucose levels for better glucose level control among diabetics.
    Device Description
    The EZ Smart Blood Glucose Test Strips are used with the EZ Smart Blood Glucose Meter to measure glucose (sugar) in whole blood. The EZ Smart Test Strips are for testing outside the body (in vitro diagnostic use). The EZ Smart Blood Glucose Monitoring System is intended for use in the home and in professional settings to monitor blood glucose levels. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.
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