DreamStation Cellular Modem with Oximetry, Australia


Product Overview

DreamStation Cellular Modem with Oximetry, Australia
DreamStation - DreamStation Cellular Modem with Oximetry, AU


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: 00606959048966

    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


    GMDN ®. © GMDN Agency 2005-2024.
    Educational Resources
    Videos