Product Overview

Pneupac - 520A1125NONEU


Device Description

A device designed to provide or assist ventilation in a patient who is apnoeic or exhibits inadequate respiration through automatic pneumatic-driven pressure cycle functions. It is connected to a source of compressed oxygen (O2) and, if not entrained, medical air via oxygen/air terminal units or gas cylinder(s). It typically includes gas supply tubing, a breathing circuit with, e.g., a gas control modulator, gas connector(s), safety valves, and a flex connector to connect to a face mask or endotracheal (ET) tube. It is used in ambulances, intensive care units (ICU), during internal patient transfer, accident and emergency (A&E), and mass casualty incidents (MCI). This is a reusable device.


Environmental Conditions

  • Handling Environment Atmospheric Pressure - KiloPascal
    • 1100.00
    • 465.00
  • Handling Environment Humidity - Percent (%) Relative Humidity
    • 95.00
    • 25.00
  • Handling Environment Temperature - Degrees Celsius
    • 50.00
    • -10.00
  • Storage Environment Atmospheric Pressure - KiloPascal
    • 1700.00
    • 465.00
  • Storage Environment Humidity - Percent (%) Relative Humidity
    • 95.00
    • 25.00

  • Device Sizes

    No Data Available


    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available


    Product Codes

    Code: BTL

    Device Name: Ventilator, Emergency, Powered (Resuscitator)

    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: 868.5925

    Third Party Flag: N

    Medical Specialty: AN


    Device Identifiers

    Device Id: 15019517189513

    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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