BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    HITACHI HEALTHCARE AMERICAS

    DI: 00869047000417 · Model: UST-9150 · Fujifilm Healthcare Americas Corporation
    View on AccessGUDID
    Product Codes
    3
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    HITACHI HEALTHCARE AMERICAS
    Primary DI
    00869047000417
    Version / Model
    UST-9150
    Company Name
    Fujifilm Healthcare Americas Corporation
    Labeler DUNS
    603156043
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-07-23
    Public Version
    3
    Public Version Date
    2021-07-29
    Public Version Status
    Update
    Public Device Record Key
    43244256-3cf0-416b-a9eb-7d4bd105c732
    Distribution End Date
    2021-06-30

    Device Description

    Ultrasound transducer

    Device Characteristics

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

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    Yes
    Sterilization Methods
    Hydrogen Peroxide

    Product Codes

    Code Name
    IYO System, Imaging, Pulsed Echo, Ultrasonic
    ITX Transducer, Ultrasonic, Diagnostic
    IYN System, Imaging, Pulsed Doppler, Ultrasonic

    GMDN Terms

    Code Name
    40770 Surgical ultrasound imaging transducer

    Identifiers

    Type ID
    Primary 00869047000417