AF541 Mask with Entrainment Elbow, Leak 1, with CapStrap, Large


Product Overview

AF541 Mask with Entrainment Elbow, Leak 1, with CapStrap, Large
AF541 - AF541 Mask EE, Leak 1 w/ CAPSTRAP, Large, US


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: 30606959024428

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 00606959024427

    Package Quantity: 10

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

    Package Status: Not in Commercial Distribution

    Package Type: Multipack


    Device Id: 00606959024427

    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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