BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    CV Web

    DI: 00840682107921 · Model: 3 · GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    CV Web
    Primary DI
    00840682107921
    Version / Model
    3
    Company Name
    GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
    Labeler DUNS
    784985108
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-05-13
    Public Version
    4
    Public Version Date
    2020-07-06
    Public Version Status
    Update
    Public Device Record Key
    9e8373d3-53fe-4d2c-9a07-1fb208aadb25

    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
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    DQK COMPUTER, DIAGNOSTIC, PROGRAMMABLE

    GMDN Terms

    Code Name
    44098 Cardiology information system application software

    Identifiers

    Type ID
    Primary 00840682107921

    Customer Contacts

    Phone
    +1(800)558-7044
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K110132 000
    K130155 000
    K152993 000