BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Blood Ketone Control solution(level 3)

    DI: 06971404131604 · Model: CM211 · e-Linkcare Meditech Co., Ltd
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Blood Ketone Control solution(level 3)
    Primary DI
    06971404131604
    Version / Model
    CM211
    Company Name
    e-Linkcare Meditech Co., Ltd
    Labeler DUNS
    540481217
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-05-17
    Public Version
    3
    Public Version Date
    2023-10-18
    Public Version Status
    Update
    Public Device Record Key
    b2fd8dac-745f-4386-ad92-763ba0fa4e27

    Device Description

    It is used to confirm that your Blood Ketone Test Strips and Multi-Monitoring Meter are working together properly and that you are performing the test correctly.

    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
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    JIN Nitroprusside, Ketones (Urinary, Non-Quant.)

    GMDN Terms

    Code Name
    62643 Multiple clinical chemistry analyte monitoring system IVD, home-use

    Identifiers

    Type ID
    Primary 06971404131604