AF421 Mask with Standard Elbow, Extra Large, Global


Product Overview

AF421 Mask with Standard Elbow, Extra Large, Global
AF421 - AF421 Mask with Standard Elbow, Extra Large, Global


Device Description

A non-sterile, flexible, form-shaped device designed to be placed over a user's nose and mouth to interface with a continuous positive airway pressure (CPAP) or bi-level positive airway pressure (BPAP) unit to provide the respiratory tract with direct ambient air, or medical oxygen (O2) and air, at a higher pressure than ambient air for noninvasive positive pressure ventilation (NPPV). It is typically made of plastic/silicone materials that create an airtight seal around the nose and mouth. It is available in various designs and sizes and stabilized with a headstrap. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.


Environmental Conditions

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

  • Device Sizes

    No Data Available


    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: CBK

    Device Name: Ventilator, Continuous, Facility Use

    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: Y

    Unclassified Reason: N/A

    Implant Flag: N

    Target Area: N/A

    Regulation Number: 868.5895

    Third Party Flag: N

    Medical Specialty: AN


    Device Identifiers

    Device Id: 30606959008497

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 00606959008496

    Package Quantity: 10

    Package Discontinue Date: 12/31/1999 12:00:00 AM

    Package Status: Not in Commercial Distribution

    Package Type: Multipack


    Device Id: 00606959008496

    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


    Device Id: 40606959008494

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 00606959008496

    Package Quantity: 20

    Package Discontinue Date: 12/31/1999 12:00:00 AM

    Package Status: Not in Commercial Distribution

    Package Type: Multipack


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