BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    OneTouch Verio

    DI: 00353885012423 · Model: 013-046 · LifeScan Europe GmbH
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    25

    Basic Information

    Brand Name
    OneTouch Verio
    Primary DI
    00353885012423
    Version / Model
    013-046
    Company Name
    LifeScan Europe GmbH
    Labeler DUNS
    480240820
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    25
    Record Status
    Published
    Publish Date
    2021-09-18
    Public Version
    1
    Public Version Date
    2021-09-27
    Public Version Status
    New
    Public Device Record Key
    3c72bfaa-559d-4f3e-b37c-0d1864d4a39a

    Device Description

    OneTouch Verio Test Strips. For Blood glucose testing with OneTouch Verio Family of Meters. For in vitro diagnostic use. For self-testing.

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    Yes
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    LFR Glucose Dehydrogenase, Glucose
    NBW System, Test, Blood Glucose, Over The Counter

    GMDN Terms

    Code Name
    53303 Glucose IVD, kit, electrometry

    Identifiers

    Type ID
    Package 20353885012427
    Primary 00353885012423
    Unit of Use 80353885012429

    Premarket Submissions

    Submission Number Supplement Number
    K110637 000
    K120708 000
    K131363 000