BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Discovery MI Columbird mE2 Application SW

    DI: 00840682141994 · Model: 2.0 · GE MEDICAL SYSTEMS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Discovery MI Columbird mE2 Application SW
    Primary DI
    00840682141994
    Version / Model
    2.0
    Company Name
    GE MEDICAL SYSTEMS, INC.
    Labeler DUNS
    809785715
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-08-03
    Public Version
    1
    Public Version Date
    2018-09-03
    Public Version Status
    New
    Public Device Record Key
    193a107f-4b79-49f3-806b-4069b9c1ca82

    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
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    KPS System, tomography, computed, emission

    GMDN Terms

    Code Name
    40644 PET system

    Identifiers

    Type ID
    Primary 00840682141994

    Premarket Submissions

    Submission Number Supplement Number
    K180318 000