BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    FUKUDA DENSHI

    DI: 04538612915901 · Model: OP210-02TGUFLS · FUKUDA DENSHI CO.,LTD.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    FUKUDA DENSHI
    Primary DI
    04538612915901
    Version / Model
    OP210-02TGUFLS
    Company Name
    FUKUDA DENSHI CO.,LTD.
    Labeler DUNS
    690671011
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-04-16
    Public Version
    1
    Public Version Date
    2024-04-24
    Public Version Status
    New
    Public Device Record Key
    c3ca7b4b-9454-4214-a894-4db427568ff6

    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
    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
    DPS Electrocardiograph

    GMDN Terms

    Code Name
    16754 Electrocardiographic recording paper

    Identifiers

    Type ID
    Primary 04538612915901

    Premarket Submissions

    Submission Number Supplement Number
    K173226 000