BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    My Baby's Heartbeat Bear Fetal Doppler

    DI: 06970442090317 · Model: FD-590B · Vcomin Technlogy Limited
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    My Baby's Heartbeat Bear Fetal Doppler
    Primary DI
    06970442090317
    Version / Model
    FD-590B
    Company Name
    Vcomin Technlogy Limited
    Labeler DUNS
    548312355
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-11-25
    Public Version
    2
    Public Version Date
    2023-08-09
    Public Version Status
    Update
    Public Device Record Key
    e04f7a5d-d4cd-4b21-ab83-78ab73ab51cb

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    Yes
    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
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    KNG Monitor, Ultrasonic, Fetal

    GMDN Terms

    Code Name
    34040 Foetal Doppler system

    Identifiers

    Type ID
    Package 16970442090314
    Primary 06970442090317

    Premarket Submissions

    Submission Number Supplement Number
    K182526 000