BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Engage Medical Device Alarm Notification System (EMDAN)

    DI: 00860002177755 · Model: EMDAN 2.4.0 · STRYKER CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Engage Medical Device Alarm Notification System (EMDAN)
    Primary DI
    00860002177755
    Version / Model
    EMDAN 2.4.0
    Catalog Number
    910-01958
    Company Name
    STRYKER CORPORATION
    Labeler DUNS
    078470558
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-01-27
    Public Version
    2
    Public Version Date
    2023-10-05
    Public Version Status
    Update
    Public Device Record Key
    f16c2057-9ce8-4bd3-9e9d-063cce3836b6

    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
    MSX System, network and communication, physiological monitors

    GMDN Terms

    Code Name
    40573 Alarm application software

    Identifiers

    Type ID
    Primary 00860002177755

    Premarket Submissions

    Submission Number Supplement Number
    K130339 000