BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Blood Ketone Monitoring System

    DI: 06971404130911 · Model: PM900B · e-Linkcare Meditech Co., Ltd
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    5
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Blood Ketone Monitoring System
    Primary DI
    06971404130911
    Version / Model
    PM900B
    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
    2021-12-17
    Public Version
    4
    Public Version Date
    2023-10-18
    Public Version Status
    Update
    Public Device Record Key
    ea0e18bb-9188-4cf6-9786-7a8f93c452e0

    Device Description

    Blood ketone Monitoring Meter with Blood Ketone Test Strips are intended for use for the quantitative measurement of B -hydroxybutyrate (B -ketone) in fresh capillary whole blood or venous whole blood.

    Device Characteristics

    Single Use
    No
    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
    Yes
    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
    Package 16971404130918
    Primary 06971404130911
    Package 26971404130915
    Package 26971404131332
    Package 36971404131339