BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Venue Go

    DI: 00840682190503 · Model: R3 · GE Medical Systems, Ultrasound & Primary Care Diagnostics LLC
    View on AccessGUDID
    Product Codes
    3
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Venue Go
    Primary DI
    00840682190503
    Version / Model
    R3
    Company Name
    GE Medical Systems, Ultrasound & Primary Care Diagnostics LLC
    Labeler DUNS
    080418188
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-11-24
    Public Version
    3
    Public Version Date
    2026-02-23
    Public Version Status
    Update
    Public Device Record Key
    8674d5d5-9297-4d19-89f9-fda2272c870a

    Device Description

    Venue Go R3 Final Assembly

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

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    ITX Transducer, ultrasonic, diagnostic
    IYO System, imaging, pulsed echo, ultrasonic
    IYN System, imaging, pulsed doppler, ultrasonic

    GMDN Terms

    Code Name
    40761 General-purpose ultrasound imaging system

    Identifiers

    Type ID
    Primary 00840682190503

    Customer Contacts

    Phone
    +1(800)437-1171
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K202233 000

    Storage Conditions

    Type
    Storage Environment Humidity
    Temperature Range
    10 – 70 Percent (%) Relative Humidity
    Type
    Storage Environment Atmospheric Pressure
    Temperature Range
    70 – 106 KiloPascal
    Type
    Handling Environment Atmospheric Pressure
    Temperature Range
    70 – 106 KiloPascal
    Type
    Storage Environment Temperature
    Temperature Range
    -20 – 60 Degrees Celsius
    Type
    Handling Environment Humidity
    Temperature Range
    30 – 85 Percent (%) Relative Humidity
    Type
    Handling Environment Temperature
    Temperature Range
    10 – 40 Degrees Celsius