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510(k) Data Aggregation

    K Number
    K171802
    Device Name
    ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device)
    Manufacturer
    Bayer HealthCare LLC
    Date Cleared
    2018-03-07

    (261 days)

    Product Code
    NUH, NYN
    Regulation Number
    882.5890
    Why did this record match?
    Applicant Name (Manufacturer) :

    Bayer HealthCare LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities. For symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.
    Device Description
    The ALEVE® Direct Therapy® device is a battery powered transcutaneous electrical nerve stimulator (TENS) device for relieving lower back pain. The device is comprised of a TENS generator with integral electrodes, two replaceable "AAA" size batteries, replaceable electroconductive hydrogel pads (Gel Pads), and a Mobile App to control the TENS device via Bluetooth® connection, which installs to Apple® iOS® 9.0 or higher or Android® 4.4 or higher smartphone platforms. Additionally, the TENS intensity may be increased or decreased using onboard mechanical buttons on the TENS unit enclosure. The TENS device offers an optional handheld, wireless remote control via Radio Frequency (RF) connection which is sold separate and comes with one replaceable CR2032 Lithium-ion coin battery.
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    K Number
    K130265
    Device Name
    CONTOUR NEXT EZ BLOOD GLUCOSE METER
    Manufacturer
    BAYER HEALTHCARE LLC
    Date Cleared
    2014-06-23

    (504 days)

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

    BAYER HEALTHCARE LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CONTOUR®NEXT EZ blood glucose nonitoring system is an over the counter (OTC) device utilized for self-esting by persons with diabetes at home for the quantiative measurement of glucose in whole patient use only, and should not be shared. The CONTOUR® NEXT EZ blood glucose monitoring system is indicated for use with fresh fingertip capillary whole blood samples. The clinical utility of this device is to aid in monitoring the effectiveness of your diabetes control program. The CONTOUR® NEXT EZ blood glucose monitoring system is not intended for use for screening for diabetes mellitus and is not intended for use on neonates. The CONTOUR® NEXT test strips are intended for self-testing by persons with diabetes for the quantitative measurement of glucose in whole blood samples from 20 to 600 mg/dL.
    Device Description
    The Contour Next EZ Blood Glucose Meter consists of a small handheld blood glucose meter that utilizes dry reagent test strips for the measurement of glucose in capillary whole blood by persons with diabetes. Liquid control solution is used to check the performance of the system. The meter, together with the test strips and control solutions, is referred to as the Contour Next EZ Blood Glucose Monitoring System. The chemical principle utilized for both the predicate and modified devices is based on measurement of electrical current caused by the reaction of glucose in the blood with chemicals on the reagent strip. The blood sample is drawn into the tip of the reagent strip through capillary action. Glucose in the sample reacts with FAD glucose dehydrogenase (FAD-GDH) enzyme on the reagent strip. The electrons generated by this reaction are shuttled to an electrode by a mediator chemical, producing a current that is proportional to the glucose in the sample. After a fixed reaction time, the glucose concentration in the sample is calculated and displayed.
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    K Number
    K121190
    Device Name
    CONTOUR NEXT BLOOD GLUCOSE METER
    Manufacturer
    BAYER HEALTHCARE LLC
    Date Cleared
    2012-07-26

    (98 days)

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

    BAYER HEALTHCARE LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CONTOUR®NEXT Blood Glucose Monitoring System is an over the counter (OTC) device utilized by persons with diabetes in home settings for the measurement of glucose in whole blood, and is for single-patient use only and should not be shared. The CONTOUR®NEXT Blood Glucose Monitoring System is indicated for use with fresh capillary whole blood samples drawn from the fingertip and palm only. CONTOUR®NEXT Test Strips are intended for self-testing by persons with diabetes for the quantitative measurement of glucose in whole blood samples from 20 to 600 mg/dL. The CONTOUR®NEXT Control Solutions are aqueous glucose solutions intended for use in self-testing by people with diabetes as a quality control check. The CONTOUR®NEXT Blood Glucose Monitoring System is not intended for the diagnosis of or screening for diabetes mellitus and is not intended for use on neonates.
    Device Description
    The CONTOUR® NEXT Blood Glucose Monitoring System consists of a small handheld blood glucose meter that utilizes dry reagent test strips and liquid controls for the measurement of glucose in capillary whole blood by persons with diabetes. The meter together with the test strips and control solutions is referred to as the CONTOUR® NEXT Blood Glucose Monitoring System.
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    K Number
    K093930
    Device Name
    DIDGET WORLD REPORTS
    Manufacturer
    BAYER HEALTHCARE LLC
    Date Cleared
    2010-03-12

    (80 days)

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

    BAYER HEALTHCARE LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    DIDGET® World Reports Diabetes Management Software is an over-the-counter software program for use by healthcare professionals and patients with diabetes for viewing and printing reports that display blood sugar readings from Bayer's DIDGET® blood glucose meter.
    Device Description
    This software application allows the transfer of blood glucose results, along with time, date, and certain data markers, from Bayer's DIDGET® blood glucose meter to the DIDGET®World Reports web server through the use of a USB cable. Data analysis includes allowing the home-user or healthcare professional to view the data in five different ways: Electronic logbook where all of the data can be seen Glucose trend of the results by date Daily blood glucose trend (standard day) Weekly blood glucose trend (standard week) Summary chart (histogram or pie chart)
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    K Number
    K052242
    Device Name
    ADVIA CHEMISTRY MICROALBUMIN CONTROLS
    Manufacturer
    BAYER HEALTHCARE LLC
    Date Cleared
    2005-10-03

    (47 days)

    Product Code
    JJW, JJY
    Regulation Number
    862.1660
    Why did this record match?
    Applicant Name (Manufacturer) :

    BAYER HEALTHCARE LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ADVIA Chemistry Microalbumin Control is intended for in vitro diagnostic use in the control of the ADVIA® Chemistry systems for the Microalbumin method.
    Device Description
    The ADVIA® Chemistry Microalbumin Controls is a human urine based solution containing various constituents.
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