BEUDAMED
    Product Code: OUG FDA class 1 21 CFR 880.6310

    Medical Device Data System

    General Hospital

    The Medical Device Data System (MDDS) (product code OUG) is a Class 1 device intended to perform one or more of the following functions without controlling or altering connected medical devices: electronic transfer, storage, conversion, or display of medical device data. It may include software, electronic hardware, physical communications media, modems, interfaces, and communications protocols. As an FDA Class 1 device under regulation 880.6310, it is subject to general controls only and falls within the General Hospital specialty. It is specifically excluded from devices used in active patient monitoring, is not an implant, and is not life-sustaining.

    View on FDA
    510(k)s
    1
    FEI Numbers
    308
    Registration Numbers
    308
    Unique Applicants
    1
    Years Active
    —

    Basic Information

    Product Code
    OUG
    Device Class
    FDA class 1
    Regulation Number
    880.6310
    Medical Specialty
    General Hospital
    Review Panel
    HO
    Submission Type
    4

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    A medical device data system (mdds) is a device that is intended to provide one or more of the following uses, without controlling or altering the functions or parameters of any connected medical devices: (i) the electronic transfer of medical device data; (ii) the electronic storage of medical device data; (iii) the electronic conversion of medical device data from one format to another format in accordance with a preset specification; or (iv) the electronic display of medical device data. (2) An MDDS may include software, electronic or electrical hardware such as a physical communications medium (including wireless hardware), modems, interfaces, and a communications protocol. This identification does not include devices intended to be used in connection with active patient monitoring.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 1 510(k) clearance via K numbers.

    K Number Device Name
    K122361 T:CONNECT DATA MANAGEMENT SYSTEM

    FEI Numbers

    This FDA classification entry is associated with 308 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 308 registration numbers. Click on an entry to view related FDA registrations.