BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Holter Analysis Software

    DI: M581NEMK1600 · Model: Basic · Northeast Monitoring, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Holter Analysis Software
    Primary DI
    M581NEMK1600
    Version / Model
    Basic
    Catalog Number
    NEMK160
    Company Name
    Northeast Monitoring, Inc.
    Labeler DUNS
    837441815
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-10-27
    Public Version
    1
    Public Version Date
    2021-11-04
    Public Version Status
    New
    Public Device Record Key
    0474ec57-21a5-4e94-aef1-65bdbe54574c

    Device Description

    Holter Analysis Software Basic

    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
    No
    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
    43239 Cardiac arrhythmia monitoring system

    Identifiers

    Type ID
    Primary M581NEMK1600

    Premarket Submissions

    Submission Number Supplement Number
    K930564 000