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510(k) Data Aggregation

    K Number
    K193475
    Device Name
    OneTouch Verio Reflect Blood Glucose Monitoring System
    Manufacturer
    LifeScan Europe GmbH
    Date Cleared
    2020-02-14

    (60 days)

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

    LifeScan Europe GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OneTouch Verio Reflect Blood Glucose Monitoring System is composed of the OneTouch Verio Reflect Meter and OneTouch Verio Test Strips. The OneTouch Verio Reflect 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 Reflect Blood Glucose Monitoring System is intended for self-testing outside the body (in-vitro diagnostic use), by individuals with diabetes at home as an aid to monitor the effectiveness of diabetes control. This system is intended to be used by a single person and should not be shared. The system should not be used for the diagnosis of, or screening for diabetes or for neonatal use.
    Device Description
    The OneTouch Verio Reflect Blood Glucose Monitoring System consists of the OneTouch Verio Reflect Blood Glucose Meter, OneTouch Verio Test Strips, OneTouch Verio Level 3 and Level 4 Control Solutions, Lancing Device and Sterile Lancets. The OneTouch Verio Reflect 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. The OneTouch Verio Reflect meter also contains tools to aid diabetes management which include a dynamic range indicator, test tracker, blood sugar mentor, trend90 average blood glucose and meal and advanced tagging.
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    K Number
    K163357
    Device Name
    OneTouch Via On-Demand Insulin Delivery System
    Manufacturer
    LifeScan Europe, a division of Cilag GmbH
    Date Cleared
    2017-06-07

    (189 days)

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

    LifeScan Europe, a division of Cilag GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The One Touch Via™ On-Demand Insulin Delivery System is intended for subcutaneous, bolus delivery of insulin for the management of diabetes mellitus in adult persons requiring insulin.
    Device Description
    The OneTouch Via™ On-Demand Insulin Delivery System (IDS) consists of a sterile, non-pyrogenic, single-use, external, disposable, ambulatory, Insulin Delivery Device (IDD, "Patch," "the Patch"), reusable Inserter, a single use, non-pyrogenic, sterile, syringe and needle ("Fill Syringe"), a Dose Count Reminder Card, and a sheet of Change by Stickers. The device is intended for subcutaneous delivery of insulin and is adhered to the skin for up to 72 hours using a biocompatible adhesive. The IDD is a manual, user filled, positive volume displacement, bolus dosing pump. The Inserter is used to place the IDD on the skin and simultaneously implant the cannula into the subcutaneous tissue. The Fill Syringe is used by the patient to fill the IDD with insulin prior to deployment on the body. The Fill Syringe and IDD have a maximum capacity of 2ml. The Dose Count Card is utilized as a reminder by the patient during the dosing session. The Change by Sticker indicates to the user the day and time (AM or PM) to remove and replace the patch. The OneTouch Via™ IDS is constructed from biocompatible plastics, elastomers, and stainless steel.
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    K Number
    K151611
    Device Name
    OneTouch Ultra Plus Flex Blood Glucose Monitoring System
    Manufacturer
    LIFESCAN EUROPE
    Date Cleared
    2015-12-14

    (182 days)

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

    LIFESCAN EUROPE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OneTouch Ultra Plus Flex 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 fingertip. The OneTouch Ultra Plus Flex Blood Glucose Monitoring System is intended to be used by a single patient and should not be shared. The OneTouch Ultra Plus Flex 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 Ultra Plus Flex Blood Glucose Monitoring System is not to be used for the diagnosis of or screening of diabetes, or for neonatal use. The OneTouch Ultra Plus Test Strips are for use with the OneTouch Ultra Plus Flex Blood Glucose Meter to quantitatively measure glucose drawn from the fingertips.
    Device Description
    The OneTouch Ultra Plus Flex Blood Glucose Monitoring System consists of the OneTouch Ultra Plus Flex Blood Glucose Meter, OneTouch Ultra Plus Test Strips, OneTouch Ultra Plus Level 3 and Level 4 Control Solutions, Lancing Device and Sterile Lancets. The OneTouch Ultra Plus Flex 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
    K150214
    Device Name
    OneTouch Verio Flex Blood Glucose Monitoring System
    Manufacturer
    LIFESCAN EUROPE
    Date Cleared
    2015-07-31

    (182 days)

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

    LIFESCAN EUROPE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The OneTouch Verio Flex™ 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 fingertip. The OneTouch Verio Flex™ Blood Glucose Monitoring System is intended to be used by a single patient and should not be be shared. OneTouch Verio Flex™ 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 Flex™ 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 Flex™ Blood Glucose Meter to quantitatively measure glucose drawn from the fingertips.
    Device Description
    The OneTouch Verio Flex Blood Glucose Monitoring System consists of the OneTouch Verio Flex Blood Glucose Meter, OneTouch® Verio® Test Strips, OneTouch® Verio® Level 3 and Level 4 Control Solutions, Lancing Device and Sterile Lancets. The OneTouch Verio Flex 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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