BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    B-Right Screen Fetal Heart

    DI: 03760415600000 · Model: V1.0.0 · BRIGHTHEART
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    B-Right Screen Fetal Heart
    Primary DI
    03760415600000
    Version / Model
    V1.0.0
    Company Name
    BRIGHTHEART
    Labeler DUNS
    279036039
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2025-01-28
    Public Version
    2
    Public Version Date
    2025-12-29
    Public Version Status
    Update
    Public Device Record Key
    62ca821c-d557-407a-afeb-fb4187ef962f

    Device Description

    Fetal EchoScan is a machine learning-based decision support system, indicated as an adjunct to fetal ultrasound examination in pregnant women anatomic ultrasound exams.

    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
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    POK Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer

    GMDN Terms

    Code Name
    40873 Ultrasound imaging system application software

    Identifiers

    Type ID
    Primary 03760415600000