BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Monitoring Waveform Viewer

    DI: 00812345029819 · Model: 11093-002-50 · MORTARA INSTRUMENT, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Monitoring Waveform Viewer
    Primary DI
    00812345029819
    Version / Model
    11093-002-50
    Company Name
    MORTARA INSTRUMENT, INC.
    Labeler DUNS
    062046149
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-24
    Public Version
    4
    Public Version Date
    2020-06-29
    Public Version Status
    Update
    Public Device Record Key
    69007fd3-90e7-4206-9cbf-bade668ece0e

    Device Description

    Cardiology Data Management System

    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
    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
    37176 Patient monitoring system module, electrocardiographic, telemetric

    Identifiers

    Type ID
    Primary 00812345029819

    Customer Contacts

    Phone
    888-667-8272
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K141811 000