BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Tyson Bio HT100-B Control Solution Level 3

    DI: 04719869704160 · Model: HT100-B · TYSON BIORESEARCH INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    4
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Tyson Bio HT100-B Control Solution Level 3
    Primary DI
    04719869704160
    Version / Model
    HT100-B
    Company Name
    TYSON BIORESEARCH INC.
    Labeler DUNS
    658026104
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-02-17
    Public Version
    1
    Public Version Date
    2023-02-27
    Public Version Status
    New
    Public Device Record Key
    acbe0840-76d1-4d57-9b54-9d1ec98626fa

    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
    41819 Glucose IVD, control

    Identifiers

    Type ID
    Package 14719869704167
    Primary 04719869704160
    Package 24719869704164
    Package 34719869704161

    Premarket Submissions

    Submission Number Supplement Number
    K170079 000