BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    TysonBio AC500 Control Solution (Level 2)

    DI: 04719869703156 · Model: AC500 · TYSON BIORESEARCH INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    4
    Pkg Device Count
    1

    Basic Information

    Brand Name
    TysonBio AC500 Control Solution (Level 2)
    Primary DI
    04719869703156
    Version / Model
    AC500
    Company Name
    TYSON BIORESEARCH INC.
    Labeler DUNS
    658026104
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-04-15
    Public Version
    2
    Public Version Date
    2022-04-08
    Public Version Status
    Update
    Public Device Record Key
    e55df1be-3317-47f3-ab54-af3de3bff93f

    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 14719869703153
    Primary 04719869703156
    Package 24719869703150
    Package 34719869703157

    Premarket Submissions

    Submission Number Supplement Number
    K123087 000