BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Tesla M3 Remote Monitor

    DI: 04255629200492 · Model: Tesla M3 Remote Monitor · MIPM Mammendorfer Institut für Physik und Medizin GmbH
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Tesla M3 Remote Monitor
    Primary DI
    04255629200492
    Version / Model
    Tesla M3 Remote Monitor
    Catalog Number
    5450012
    Company Name
    MIPM Mammendorfer Institut für Physik und Medizin GmbH
    Labeler DUNS
    324416379
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-12-13
    Public Version
    1
    Public Version Date
    2023-12-21
    Public Version Status
    New
    Public Device Record Key
    6fad107b-1dd7-4f47-9eb0-6c4b73015f92

    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
    MR Unsafe
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)

    GMDN Terms

    Code Name
    61161 MRI-patient physiologic monitoring system

    Identifiers

    Type ID
    Primary 04255629200492
    Previous EMIP54500120

    Customer Contacts

    Phone
    +49814592090
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K142032 000