BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Cardio Server

    DI: 00860991000379 · Model: 7.0 · EPIPHANY HEALTHCARE DATA MANAGEMENT, LLC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Cardio Server
    Primary DI
    00860991000379
    Version / Model
    7.0
    Company Name
    EPIPHANY HEALTHCARE DATA MANAGEMENT, LLC
    Labeler DUNS
    079747524
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-10-31
    Public Version
    1
    Public Version Date
    2022-11-08
    Public Version Status
    New
    Public Device Record Key
    c5de67b2-0993-46c7-aaf5-b0078a89676e

    Device Description

    ECG Management System is a software only EGG management database that stores, displays, and prints high resolution EGG data

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    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
    No
    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
    DQK Computer, Diagnostic, Programmable

    GMDN Terms

    Code Name
    44098 Cardiology information system application software

    Identifiers

    Type ID
    Primary 00860991000379

    Premarket Submissions

    Submission Number Supplement Number
    K052883 000