BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    GE

    DI: 00883489001795 · Model: GE333 · BIONIME CORPORATION
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    4
    Pkg Device Count
    1

    Basic Information

    Brand Name
    GE
    Primary DI
    00883489001795
    Version / Model
    GE333
    Company Name
    BIONIME CORPORATION
    Labeler DUNS
    658637244
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-03-25
    Public Version
    1
    Public Version Date
    2019-04-02
    Public Version Status
    New
    Public Device Record Key
    1e307c1d-7d64-417e-96af-1cc07fc190fe

    Device Description

    GE333 control solution(Normal Level)

    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
    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
    JJX Single (Specified) Analyte Controls (Assayed And Unassayed)

    GMDN Terms

    Code Name
    41819 Glucose IVD, control

    Identifiers

    Type ID
    Package 20883489001805
    Package 10883489001808
    Package 00883489001801
    Primary 00883489001795

    Storage Conditions

    Type
    Handling Environment Temperature
    Temperature Range
    2 – 30 Degrees Celsius