BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Kosmos OTS Android Doppler Software Package

    DI: 09353278000700 · Model: P007701 · ECHONOUS, INC.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Kosmos OTS Android Doppler Software Package
    Primary DI
    09353278000700
    Version / Model
    P007701
    Company Name
    ECHONOUS, INC.
    Labeler DUNS
    080481089
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-02-03
    Public Version
    1
    Public Version Date
    2023-02-13
    Public Version Status
    New
    Public Device Record Key
    fb6b6500-ef14-44b7-87f6-e857effcc384

    Device Description

    Kosmos OTS Android Doppler Software Package

    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
    No
    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
    IYO System, Imaging, Pulsed Echo, Ultrasonic
    IYN System, Imaging, Pulsed Doppler, Ultrasonic

    GMDN Terms

    Code Name
    40873 Ultrasound imaging system application software

    Identifiers

    Type ID
    Primary 09353278000700

    Premarket Submissions

    Submission Number Supplement Number
    K193518 000
    K212100 000