BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Summit Doppler

    DI: 00888937011364 · Model: VANMAX · Coopersurgical, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Summit Doppler
    Primary DI
    00888937011364
    Version / Model
    VANMAX
    Company Name
    Coopersurgical, Inc.
    Labeler DUNS
    801895244
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-07-28
    Public Version
    6
    Public Version Date
    2024-02-28
    Public Version Status
    Update
    Public Device Record Key
    0f3346a8-4b57-4255-8b82-72ac285aa74e

    Device Description

    Vantage ABI System Contents: Two 10cm cuffs, two 12cm cuffs, four color-coded hoses; reporting software CD, USB memory stick, roll stand with basket, ABI report forms and built-in printer.

    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
    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
    DXN System, Measurement, Blood-Pressure, Non-Invasive

    GMDN Terms

    Code Name
    44311 Noninvasive vascular ultrasound system

    Identifiers

    Type ID
    Primary 00888937011364

    Premarket Submissions

    Submission Number Supplement Number
    K103693 000