BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    FDK

    DI: 00859020006116 · Model: FT-C15Y-V · Fudakang Industrial Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    5
    Pkg Device Count
    1

    Basic Information

    Brand Name
    FDK
    Primary DI
    00859020006116
    Version / Model
    FT-C15Y-V
    Company Name
    Fudakang Industrial Inc.
    Labeler DUNS
    118811334
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-12-21
    Public Version
    9
    Public Version Date
    2023-10-23
    Public Version Status
    Update
    Public Device Record Key
    4149a32e-d64c-4555-94cb-ecfdb60fb135

    Device Description

    FDK ARM CUFF BP MONITOR

    Device Characteristics

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

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    DXN System, Measurement, Blood-Pressure, Non-Invasive

    GMDN Terms

    Code Name
    45617 Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

    Identifiers

    Type ID
    Primary 00859020006116
    Package 00859020006123
    Package 10859020006113
    Package 30859020006117
    Package 20859020006110