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    LifeScan Inc.

    Manufacturer
    🇺🇸 United States·1 Basic UDI-DI·1 Device

    OneTouch Reveal Insulin Mentor

    Device
    EU MDR · Eu Md Class 2a ·LifeScan Inc.·On the market·8 countries

    LIFESCAN INC.

    FDA Adverse Event
    Injury ·LIFESCAN, INC.·Product code CFR·August 7, 1997

    ONE TOUCH ULTRA2 METER

    FDA Adverse Event
    Injury ·LIFESCAN SCOTLAND LTD.·Product code CGA·February 27, 2024

    ONE TOUCH ULTRA TEST STRIPS

    FDA Adverse Event
    Death ·LIFESCAN, INC.·Product code NBW·January 31, 2007

    ONE TOUCH ULTRA TEST STRIPS

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code CGA·August 12, 2023

    OT ULTRA TEST STRIPS

    FDA Adverse Event
    Malfunction ·UNKNOWN·Product code CGA·August 12, 2023

    OT ULTRA TEST STRIPS

    FDA Adverse Event
    Malfunction ·UNKNOWN·Product code CGA·August 12, 2023

    ONE TOUCH HORIZON TEST STRIPS

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code CGA·August 12, 2023

    METER C - OT II

    FDA Adverse Event
    Injury ·LIFESCAN, INC.·Product code CFR·February 4, 2002

    SYSTEM TEST, BLOOD GLUCOSE, OVER THE COUNTER

    FDA Adverse Event
    Malfunction ·UNKNOWN·Product code NBW·August 12, 2023

    ONE TOUCH ULTRA TEST STRIPS #100

    FDA Adverse Event
    Injury ·LIFESCAN, INC·Product code NBW·July 23, 2008

    LifeScan brand OneTouch Ultra Test Strip used in LifeScan Blood Glucose Meter; Part Number 020-244-07; Distributed and Manufactured by: LifeScan, Inc., 1000 Gibraltar Drive, Milpitas, CA 95037

    FDA Recall
    Terminated ·Lifescan Inc·Product code CGA·November 17, 2003

    ONE TOUCH ULTRA

    FDA Adverse Event
    Injury ·LIFESCAN, INC.·Product code CFR·May 30, 2001

    OneTouch Reveal Insulin Mentor

    Basic UDI-DI
    EU MDR · Eu Md Class 2a ·LifeScan Inc.·1 device

    Lifescan OneTouch SureStep Meter Blood Glucose monitoring system,Product is distributed by LifeScan, Inc., 1000 Gibraltar Dr., Milpitas, CA 95037

    FDA Recall
    Terminated ·Lifescan Inc·Product code CGA·September 9, 2005

    LifeScan brand OneTouch Ultra Meter - Owner''s Booklet; Product is manufactured and distributed by LifeScan, Inc., 1000 Gibraltar Dr., Milpitas, CA 95037

    FDA Recall
    Terminated ·Lifescan Inc·Product code NBW·November 21, 2003

    LifeScan OneTouch Data Management Software Version 1.0, Part Number: 021-722-01(for OneTouch Select and UltraMini (Download) Blood Glucose Meters), LifeScan Inc, Milpitas, CA 95037.

    FDA Recall
    Terminated ·Lifescan Inc·Product code NBW·December 18, 2007

    OneTouch SureStep and SureStep Pro Test strips, for use with the OneTouch SureStep Blood Glucose Meters, in 100 count and 50 count packaging distributed by LifeScan Inc., Milpitas, CA, Manufactured by LifeScan Puerto Rico Medical device for quantitative measurement of glucose in whole blood for use in home settings (SureStep).

    FDA Recall
    Terminated ·Lifescan Inc·Product code NBW·February 24, 2010

    LifeScan brand OneTouch Sure Step- Blood Glucose Monitoring System Test Strips, 50 strips per package, Distributed and Manufactured by: LifeScan, Inc., 1000 Gibraltar Drive, Milpitas, CA 95037

    FDA Recall
    Terminated ·Lifescan Inc·Product code NBW·September 29, 2006