Medium Sized High Concentration Procedural Oxygen Mask


Product Overview

Medium Sized High Concentration Procedural Oxygen Mask
Procedural Oxygen Mask - 1001-MSA-MED


Device Description

A non-sterile, flexible, form-shaped device designed to be placed over the nose and mouth to deliver air of high oxygen (O2) concentration to a patient's airway. It typically includes two unidirectional valves, one that closes during inspiration to prevent room air mixing with oxygen in a reservoir bag, and one that closes during exhalation to prevent exhaled respiratory gases from entering the reservoir bag. It is made of soft, flexible polymers designed to create an airtight seal against the patient's face. It may include tubing, and various valves and connectors, however other respiratory equipment (e.g., nebulizer, humidifier, CPAP device) is not included. This is a single-use device.


Environmental Conditions

  • Handling Environment Temperature - Degrees Celsius
    • 50.00
    • -20.00
  • Storage Environment Temperature - Degrees Celsius
    • 50.00
    • -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: 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: 10851438008192

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 00851438008195

    Package Quantity: 30

    Package Discontinue Date: N/A

    Package Status: In Commercial Distribution

    Package Type: pack


    Device Id: 00851438008195

    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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