BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    bkt ß-Ketone & blood glucose monitoring system

    DI: 00860005745944 · Model: TD-4279 · Adam Lawrence
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    bkt ß-Ketone & blood glucose monitoring system
    Primary DI
    00860005745944
    Version / Model
    TD-4279
    Company Name
    Adam Lawrence
    Labeler DUNS
    117734901
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-03-15
    Public Version
    3
    Public Version Date
    2023-10-18
    Public Version Status
    Update
    Public Device Record Key
    6992936c-d614-4270-b436-b79723f84565

    Device Characteristics

    Single Use
    No
    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
    Yes
    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
    62643 Multiple clinical chemistry analyte monitoring system IVD, home-use

    Identifiers

    Type ID
    Primary 00860005745944