ISA OR+ and Mounting Bracket Kit


Product Overview

ISA OR+ and Mounting Bracket Kit
ISA OR+ - 9685


Device Description

A mains electricity (AC-powered) bedside device designed to measure and display a non-ambulatory patient's respiratory functions. Measurements include concentration of respiratory gas components [e.g., carbon dioxide (CO2), oxygen (O2)] and/or continuous monitoring of the inspiration/expiration cycle including respiration rate, air volume, and cessation of breathing (apnoea). The device may also measure airway pressure (Paw) and oesophageal pressure (Pes). It is typically equipped with audible and/or visual alarms that are triggered when respiratory parameters drop below or exceed pre-set limits.


Environmental Conditions

  • Handling Environment Humidity - Percent (%) Relative Humidity
    • 100.00
    • 5.00
  • Handling Environment Temperature - Degrees Celsius
    • 70.00
    • -40.00
  • Storage Environment Humidity - Percent (%) Relative Humidity
    • 100.00
    • 5.00
  • Storage Environment Temperature - Degrees Celsius
    • 70.00
    • -40.00

  • Device Sizes

    No Data Available


    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: CCK

    Device Name: Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase

    Device Class: 2

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 1

    Review Panel: AN

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: N/A

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: N

    Target Area: N/A

    Regulation Number: 868.1400

    Third Party Flag: Y

    Medical Specialty: AN


    Device Identifiers

    Device Id: 00843997009317

    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