BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    FUKUDA DENSHI

    DI: 24538612914038 · Model: TEY-162DX4-0.7A · FUKUDA DENSHI CO.,LTD.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    5
    Pkg Device Count
    4

    Basic Information

    Brand Name
    FUKUDA DENSHI
    Primary DI
    24538612914038
    Version / Model
    TEY-162DX4-0.7A
    Company Name
    FUKUDA DENSHI CO.,LTD.
    Labeler DUNS
    690671011
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    4
    Record Status
    Published
    Publish Date
    2017-06-22
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    bae49727-a58d-4757-a6c0-5649372dac30

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    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
    Yes
    Has Serial Number
    No
    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
    DRX Electrode, Electrocardiograph

    GMDN Terms

    Code Name
    35035 Electrocardiographic electrode, single-use

    Identifiers

    Type ID
    Package 84538612914030
    Package 64538612914036
    Package 44538612914032
    Primary 24538612914038
    Unit of Use 04538612914034