BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Baby Doppler

    DI: 00628055787266 · Model: Ultraline 1000 Blue 2.5MHz · DAGAMMA INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Baby Doppler
    Primary DI
    00628055787266
    Version / Model
    Ultraline 1000 Blue 2.5MHz
    Company Name
    DAGAMMA INC.
    Labeler DUNS
    080572190
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-09-28
    Public Version
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    d6ae6ddf-95ad-46dd-b203-6e43300de77c

    Device Description

    The Ultraline 1000 is an ultrasonic Doppler that allows expectant mothers and health care professionals to retrieve and listen to the fetal heart rate.

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

    Sterilization

    Is Sterile
    Yes
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    KNG Monitor, Ultrasonic, Fetal

    GMDN Terms

    Code Name
    34040 Foetal Doppler system

    Identifiers

    Type ID
    Primary 00628055787266

    Customer Contacts

    Phone
    8005902767
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K131457 000