BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    bkt ß-Ketone & blood glucose monitoring system

    DI: 00858538007127 · 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
    00858538007127
    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
    2022-09-09
    Public Version
    3
    Public Version Date
    2023-10-18
    Public Version Status
    Update
    Public Device Record Key
    ffe702a2-6c3d-4ad1-bfdb-7bdcdf7a1a48

    Device Description

    Glucose Test strip 10 PCS Ketone Test strip 10 PCS Lancing device 1 PCS Lancet 10PCS

    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 00858538007127