BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    FUKUDA DENSHI

    DI: 04538612901041 · Model: UX-600 · 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
    04538612901041
    Version / Model
    UX-600
    Company Name
    FUKUDA DENSHI CO.,LTD.
    Labeler DUNS
    690671011
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-10-26
    Public Version
    2
    Public Version Date
    2022-11-28
    Public Version Status
    Update
    Public Device Record Key
    6995a360-95f2-4080-b38c-e52e1c6e3134

    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
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)

    GMDN Terms

    Code Name
    36365 Electrocardiography monitoring system receiver

    Identifiers

    Type ID
    Primary 04538612901041

    Premarket Submissions

    Submission Number Supplement Number
    K020084 000