BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Tyson Bio 50H Control Solution (Level 2)

    DI: 04719869702364 · Model: Tyson Bio 50H · TYSON BIORESEARCH INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    4
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Tyson Bio 50H Control Solution (Level 2)
    Primary DI
    04719869702364
    Version / Model
    Tyson Bio 50H
    Company Name
    TYSON BIORESEARCH INC.
    Labeler DUNS
    658026104
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-03-11
    Public Version
    3
    Public Version Date
    2023-02-20
    Public Version Status
    Update
    Public Device Record Key
    9a4a400d-d3ea-4d6b-9e96-39f3f4f9b0ab

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    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
    41819 Glucose IVD, control

    Identifiers

    Type ID
    Primary 04719869702364
    Package 24719869702368
    Package 14719869702361
    Package 34719869702365

    Premarket Submissions

    Submission Number Supplement Number
    K170079 000