BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Monarch Software Laptop v2.1.6

    DI: B634SW0121900201060 · Model: Version 2.1.6 · AURIS HEALTH, INC.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Monarch Software Laptop v2.1.6
    Primary DI
    B634SW0121900201060
    Version / Model
    Version 2.1.6
    Company Name
    AURIS HEALTH, INC.
    Labeler DUNS
    015823456
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-03-05
    Public Version
    1
    Public Version Date
    2020-03-13
    Public Version Status
    New
    Public Device Record Key
    ebe87c3c-7f8e-4536-a392-645cea0c2ecd

    Device Description

    Monarch Software Laptop v2.1.6

    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
    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
    EOQ Bronchoscope (Flexible Or Rigid)
    JAK System, X-Ray, Tomography, Computed

    GMDN Terms

    Code Name
    40867 CT system application software

    Identifiers

    Type ID
    Primary B634SW0121900201060

    Premarket Submissions

    Submission Number Supplement Number
    K173760 000