BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    EART

    DI: 17540279105018 · Model: 10-501 · Icentia Inc.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    EART
    Primary DI
    17540279105018
    Version / Model
    10-501
    Company Name
    Icentia Inc.
    Labeler DUNS
    241983607
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-03-26
    Public Version
    3
    Public Version Date
    2025-02-24
    Public Version Status
    Update
    Public Device Record Key
    128ed7ae-514e-4767-85c8-100c853472ef

    Device Description

    ECG Analysis and Reporting Tool.

    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
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    DSH Recorder, Magnetic Tape, Medical
    DQK Computer, Diagnostic, Programmable

    GMDN Terms

    Code Name
    41651 Electrocardiographic long-term ambulatory recording analyser application software

    Identifiers

    Type ID
    Primary 17540279105018

    Premarket Submissions

    Submission Number Supplement Number
    K223049 000