BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ALGORITHM SERVICES

    DI: 00195278457547 · Model: EK12 V2 · 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
    ALGORITHM SERVICES
    Primary DI
    00195278457547
    Version / Model
    EK12 V2
    Catalog Number
    2104498-003
    Company Name
    GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.
    Labeler DUNS
    006580799
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-01-10
    Public Version
    1
    Public Version Date
    2023-01-18
    Public Version Status
    New
    Public Device Record Key
    242df7b4-af0d-4fb8-9979-54b222a88a14

    Device Description

    ALGORITHM SERVICES EK12 V2

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    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
    MHX MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS)

    GMDN Terms

    Code Name
    44098 Cardiology information system application software

    Identifiers

    Type ID
    Primary 00195278457547

    Premarket Submissions

    Submission Number Supplement Number
    K221904 000