BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Summit Doppler

    DI: 00888937010046 · Model: C250CM · Coopersurgical, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Summit Doppler
    Primary DI
    00888937010046
    Version / Model
    C250CM
    Company Name
    Coopersurgical, Inc.
    Labeler DUNS
    801895244
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-07-21
    Public Version
    5
    Public Version Date
    2024-02-28
    Public Version Status
    Update
    Public Device Record Key
    454f7dae-ed01-41d3-bea8-6a655b5b16e7

    Device Description

    LifeDop 250 Professional with 3.0 MHz and EchoHeart Transvaginal Probes

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    Yes
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    Yes
    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
    KNG Monitor, Ultrasonic, Fetal

    GMDN Terms

    Code Name
    34040 Foetal Doppler system

    Identifiers

    Type ID
    Package 60888937010048
    Primary 00888937010046

    Premarket Submissions

    Submission Number Supplement Number
    K024197 000