DreamStation Wi-Fi Accessory, with Oximetry, USA


Product Overview

DreamStation Wi
DreamStation - DreamStation Wi-Fi Accessory, US with oximetry


Device Description

An electronic unit or device assembly intended to be used to interface one or more noninvasive devices for digital communication of clinical data, typically from a patient data gathering point (e.g., patient monitor/monitoring system) to a computer/network server; it is not intended to store data, display data/images, or control other devices. It may be an ethernet router, network switch, wireless transmitter and/or receiver, or cellular device intended for wired and/or wireless transmission of data. It is not ambulatory and not patient worn.


Environmental Conditions

  • Storage Environment Humidity - Percent (%) Relative Humidity
    • 95.00
    • 15.00
  • Storage Environment Temperature - Degrees Fahrenheit
    • 140.00
    • -4.00
  • Storage Environment Temperature - Degrees Celsius
    • 60.00
    • -20.00

  • Device Sizes

    No Data Available


    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: OUG

    Device Name: Medical Device Data System

    Device Class: 1

    Physical State: Software and Electronics

    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.

    Submission Type ID: 4

    Review Panel: HO

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: Software algorithms to perform necessary medical communication functions

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: N

    Target Area: Hospital Information Systems

    Regulation Number: 880.6310

    Third Party Flag: N

    Medical Specialty: HO


    Device Identifiers

    Device Id: 00606959022898

    Device Type: Primary

    DeviceId Issuing Agency: GS1

    Contains DI Number: N/A

    Package Quantity: N/A

    Package Discontinue Date: N/A

    Package Status: N/A

    Package Type: N/A


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