BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    GE

    DI: 00883489001696 · Model: 333 · BIONIME CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    5
    Pkg Device Count
    25

    Basic Information

    Brand Name
    GE
    Primary DI
    00883489001696
    Version / Model
    333
    Company Name
    BIONIME CORPORATION
    Labeler DUNS
    658637244
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    25
    Record Status
    Published
    Publish Date
    2018-11-01
    Public Version
    1
    Public Version Date
    2018-12-03
    Public Version Status
    New
    Public Device Record Key
    b3576826-d155-4ad5-814d-71d191040d9d

    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
    NBW System, Test, Blood Glucose, Over The Counter

    GMDN Terms

    Code Name
    62537 Glucose monitoring system IVD, home-use

    Identifiers

    Type ID
    Package 20883489001706
    Package 10883489001709
    Package 00883489001702
    Primary 00883489001696
    Unit of Use 80883489001692