CPR Resuscitator Mask only,Adult


Product Overview

CPR Resuscitator Mask only,Adult
Adsafe™ - 4053M


Device Description

A flexible, form-shaped device that is placed over a patient's mouth to administer "mouth-to-mask" exhaled air from the user to the patient during cardiopulmonary resuscitation (CPR). The device is designed to replace "mouth-to-mouth" resuscitation therefore reducing the risk of cross-contamination; it is also used on manikins by students during CPR training. The device typically consists of the mask with a mouthpiece and a non-rebreathing valve and/or bacteria filter. Also referred to as a pocket face mask, it is typically used by emergency medical services (EMS). This is a reusable device.


Environmental Conditions

  • Storage Environment Humidity - Percent (%) Relative Humidity
    • 85.00
    • 15.00
  • Storage Environment Temperature - Degrees Fahrenheit
    • 122.00
    • -22.00

  • Device Sizes

    No Data Available


    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: BYG

    Device Name: Mask, Oxygen

    Device Class: 1

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 4

    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: 868.5580

    Third Party Flag: N

    Medical Specialty: AN


    Device Identifiers

    Device Id: 00634782555184

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 00634782855185

    Package Quantity: 10

    Package Discontinue Date: N/A

    Package Status: In Commercial Distribution

    Package Type: Master Case


    Device Id: 00634782855185

    Device Type: Package

    DeviceId Issuing Agency: GS1

    Contains DI Number: 00634782055400

    Package Quantity: 10

    Package Discontinue Date: N/A

    Package Status: In Commercial Distribution

    Package Type: Inner pack


    Device Id: 00634782055400

    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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