Product Overview

Pneupac - 510A1960NONEU


Device Description

A mains electricity (AC-powered) automatic cycling device intended for short-term and long-term ventilatory support for a neonatal/paediatric patient, especially those preterm and critically ill with respiratory failure in a critical care setting. It is typically a time-cycled, pressure-control device that includes a small bore flexible tube breathing system. It may be capable of high frequency oscillatory ventilation in addition to conventional ventilation, and includes positive end-expiratory pressure (PEEP) and continuous positive airway pressure (CPAP) controls.


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: 15019517181173

    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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