BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Change Healthcare Cardiology

    DI: 17540262090024 · Model: 14.1.1 · CHANGE HEALTHCARE ISRAEL LTD
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Change Healthcare Cardiology
    Primary DI
    17540262090024
    Version / Model
    14.1.1
    Company Name
    CHANGE HEALTHCARE ISRAEL LTD
    Labeler DUNS
    600748180
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-11-22
    Public Version
    1
    Public Version Date
    2018-12-24
    Public Version Status
    New
    Public Device Record Key
    b3e4484c-a7f7-4604-82c0-6b7b25a10972

    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
    MR Unsafe
    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
    LLZ System, Image Processing, Radiological

    GMDN Terms

    Code Name
    18119 Cardiology information system

    Identifiers

    Type ID
    Primary 17540262090024

    Premarket Submissions

    Submission Number Supplement Number
    K181080 000