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510(k) Data Aggregation

    K Number
    K093475
    Device Name
    BASESENS BLOOD GLUCOSE MONITORING SYSTEM
    Manufacturer
    Date Cleared
    2010-02-24

    (110 days)

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

    HYGEIA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The BaseSens I Blood Glucose Monitoring System is used for the quantitative measurement of glucose levels in capillary whole blood as an aid in monitoring the effectiveness of diabetes management at home or in clinical settings. The BaseSens I Blood Glucose Monitoring System should be used only for testing outside the body (in vitro diagnostic use only). The BaseSens I Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates. Testing sites include the fingertip along with alternate sites testing (AST) on the forearm, palm, thigh and calf. AST in this system can be used only during steady-state blood glucose conditions. BaseSens I Test Strip is used with the BaseSens I Blood Glucose Meter for quantitatively measuring glucose in capillary whole blood. The BaseSens I Test Strip is intended for self-testing outside the body (in vitro diagnostic use only). The BaseSens I Test Strips are not intended for the diagnosis of or screening for diabetes mellitus, and are not intended for use on neonates. Testing sites include the fingertip along with alternate sites testing (AST) on the forearm, palm, thigh and calf. AST in this system can be used only during steady-state blood glucose conditions. BaseSens I Control A&B Solutions are a red liquid to check that both the meters and test strips are working together properly. It contains a known range of glucose as written on the bottle.
    Device Description
    The BaseSens I Blood Glucose Monitoring System is identical to the i-Sens CareSens N Blood Glucose Monitoring System. The Hygieia BaseSens I Blood Glucose Monitoring System is a rebranded CareSens N System. Rebranding here is intended to be understood as all components of the CareSens N System have been relabeled with the Hygieia name BaseSens I or BaseSens I Blood Glucose Monitoring System. The System includes the BaseSens 1 blood glucose meter, test strips and controls.
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