AF541 Under the Nose Mask with Entrainment Elbow, Leak 1, with CapStrap, Extra Small, International


Product Overview

AF541 Under the Nose Mask with Entrainment Elbow, Leak 1, with CapStrap, Extra Small, International
AF541 - AF541 Mask EE, LEAK 1, Under the Nose, CAPSTRAP, INTL, XS


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 Celsius
    • 60.00
    • -20.00
  • 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: BZD

    Device Name: Ventilator, Non-Continuous (Respirator)

    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: 868.5905

    Third Party Flag: N

    Medical Specialty: AN


    Device Identifiers

    Device Id: 30606959046512

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 00606959046511

    Package Quantity: 10

    Package Discontinue Date: N/A

    Package Status: In Commercial Distribution

    Package Type: Multipack


    Device Id: 00606959046511

    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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