BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Sonosite MT

    DI: 00841517112172 · Model: P33009-10 · FUJIFILM SONOSITE, INC.
    View on AccessGUDID
    Product Codes
    3
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Sonosite MT
    Primary DI
    00841517112172
    Version / Model
    P33009-10
    Catalog Number
    P33009
    Company Name
    FUJIFILM SONOSITE, INC.
    Labeler DUNS
    014438860
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-11-24
    Public Version
    1
    Public Version Date
    2025-12-02
    Public Version Status
    New
    Public Device Record Key
    4ad1c9a3-b46d-4a19-8397-e4086b5beded

    Device Description

    Diagnostic Ultrasound Accessory

    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
    No

    Product Codes

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

    GMDN Terms

    Code Name
    36564 Electrical frequency meter

    Identifiers

    Type ID
    Primary 00841517112172

    Premarket Submissions

    Submission Number Supplement Number
    K253448 000

    Storage Conditions

    Type
    Handling Environment Atmospheric Pressure
    Temperature Range
    50 – 106 KiloPascal
    Type
    Handling Environment Humidity
    Temperature Range
    15 – 95 Percent (%) Relative Humidity
    Type
    Handling Environment Temperature
    Temperature Range
    -20 – 60 Degrees Celsius
    Type
    Storage Environment Atmospheric Pressure
    Temperature Range
    50 – 106 KiloPascal
    Type
    Storage Environment Humidity
    Temperature Range
    15 – 95 Percent (%) Relative Humidity
    Type
    Storage Environment Temperature
    Temperature Range
    -20 – 60 Degrees Celsius