BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    OneTouch Verio Control Solution

    DI: 00353885011969 · Model: 011818 · LifeScan Europe GmbH
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    75

    Basic Information

    Brand Name
    OneTouch Verio Control Solution
    Primary DI
    00353885011969
    Version / Model
    011818
    Catalog Number
    01181803
    Company Name
    LifeScan Europe GmbH
    Labeler DUNS
    480240820
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    75
    Record Status
    Published
    Publish Date
    2020-10-14
    Public Version
    1
    Public Version Date
    2020-10-22
    Public Version Status
    New
    Public Device Record Key
    89d7cf85-84e0-4f5d-a4de-8647f5642654

    Device Characteristics

    Single Use
    No
    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
    Yes
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
    NBW System, Test, Blood Glucose, Over The Counter

    GMDN Terms

    Code Name
    62538 Glucose monitoring system IVD, point-of-care

    Identifiers

    Type ID
    Package 20353885011963
    Primary 00353885011969
    Unit of Use 80353885011965

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    41 – 86 Degrees Fahrenheit
    Type
    Storage Environment Humidity
    Temperature Range
    – 65 Percent (%) Relative Humidity