BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Tyson Bio AC500 Blood Glucose Monitoring System

    DI: 04719869703101 · Model: AC500 · TYSON BIORESEARCH INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    3
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Tyson Bio AC500 Blood Glucose Monitoring System
    Primary DI
    04719869703101
    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
    3
    Public Version Date
    2023-09-04
    Public Version Status
    Update
    Public Device Record Key
    82118895-8788-4500-bd70-732a757767c2

    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
    No
    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 14719869703108
    Primary 04719869703101
    Package 24719869703105

    Premarket Submissions

    Submission Number Supplement Number
    K123087 000