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510(k) Data Aggregation

    K Number
    K131363
    Device Name
    ONETOUCH VERIO BLOOD GLUCOSE MONITORING SYSTEM
    Manufacturer
    CILAG GMBH INTERNATIONAL
    Date Cleared
    2013-08-30

    (109 days)

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

    CILAG GMBH INTERNATIONAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OneTouch® Verio® Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. The system is intended to be used by a single patient and should not be shared. The OneTouch® Verio® Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The OneTouch® Verio® Blood Glucose Monitoring System is not to be used for the diagnosis of or screening of diabetes or for neonatal use. The OneTouch® Verio® Test Strips are for use with the OneTouch® Verio® Blood Glucose Meter to quantitatively measure glucose drawn from the fingertips.
    Device Description
    The OneTouch® Verio® Blood Glucose Monitoring System consists of the OneTouch® Verio® Sync Blood Glucose Meter, OneTouch® Verio® Test Strips, OneTouch® Verio® Level 3 and Level 4 Control Solutions, Lancing Device and Sterile Lancets. The OneTouch® Verio® Blood Glucose Monitoring System measures the glucose content of a blood sample by means of an electrical current produced in the test strip and sent to the meter for measurement.
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    K Number
    K120708
    Device Name
    ONETOUCH VERIO SYNC BLOOD GLUCOSE MONITORING SYSTEM
    Manufacturer
    CILAG GMBH INTERNATIONAL
    Date Cleared
    2013-02-07

    (336 days)

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

    CILAG GMBH INTERNATIONAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OneTouch Verio Sync Blood Glucose Monitoring System (BGMS) is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertip. The system is intended to be used by a single person and should not be shared. The OneTouch Verio Sync BGMS is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The OneTouch Verio Sync BGMS should not be used for the diagnosis of or screening of diabetes or for neonatal use. The OneTouch Verio Test Strips are for use with the OneTouch Verio Sync Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips.
    Device Description
    The OneTouch® Verio™ Sync Blood Glucose Monitoring System consists of the OneTouch® Verio™ Sync Blood Glucose Meter, OneTouch® Verio™ Test Strips, OneTouch® Verio™ Level 3 and Level 4 Control Solutions, Lancing Device and Sterile Lancets. The OneTouch® Verio™ Sync Blood Glucose Monitoring System measures the glucose content of a blood sample by means of an electrical current produced in the test strip and sent to the meter for measurement.
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    K Number
    K110637
    Device Name
    ONETOUCH VERIO (TM) IQ BLOOD GLUCOSE MONITORING SYSTEM
    Manufacturer
    CILAG GMBH INTERNATIONAL
    Date Cleared
    2011-09-07

    (187 days)

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

    CILAG GMBH INTERNATIONAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OneTouch® Verio" "IQ Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips. The OneTouch® Verio" IQ Blood Glucose Monitoring System is intended to be used by a single patient and should not be used for testing multiple patients. OneTouch® Verio" IQ Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The OneTouch® Verio" "IQ Blood Glucose Monitoring System is not to be used for the diagnosis of or screening of diabetes, neonatal use. The OneTouch® Verio" Test Strips are for use with the OneTouch® Verio" IQ Blood Glucose Meter to quantitatively measure glucose drawn from the fingertips.
    Device Description
    The OneTouch® Verio" Verio" IQ Blood Glucose Monitoring System consists of the OneTouch Verio" " Q Blood Glucose Meter, OneTouch® Verio" Test Strips, OneTouch® Verio" Mid and High Control Solutions, Lancing Device, Sterile Lancets and Alternative Site testing Kit (available separately). The Alternative Site Testing Kit comprises the OneTouch® Lancing Device, OneTouch® UltraSoft" Sterile Lancets, OneTouch®, Clear Cap and Instructions for Use. The OneTouch® Verio" IQ Blood Glucose Monitoring System measures the glucose content of a blood sample by means of an electrical current produced in the test strip and sent to the meter for measurement.
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