Code: CBKDevice Name: Ventilator, Continuous, Facility UseDevice Class: 2Physical State: N/ADefinition: N/ASubmission Type ID: 1Review Panel: ANReview Code: N/ATechnical Method: NGmp Exempt Flag: N/ALife Sustain Support Flag: YUnclassified Reason: N/AImplant Flag: NTarget Area: N/ARegulation Number: 868.5895Third Party Flag: NMedical Specialty: AN

Device Id: 10884521172180Device Type: PrimaryDeviceId Issuing Agency: GS1Contains DI Number: N/APackage Quantity: N/APackage Discontinue Date: N/APackage Status: N/APackage Type: N/A

Handling Environment Atmospheric Pressure - KiloPascal106.0070.00Handling Environment Humidity - Percent (%) Relative Humidity95.0010.00Handling Environment Temperature - Degrees Fahrenheit104.0050.00Special Storage Condition, SpecifyFragile, Keep dry, Stacking limitations, This side upStorage Environment Atmospheric Pressure - KiloPascal106.0050.00Storage Environment Humidity - Percent (%) Relative Humidity95.0010.00Storage Environment Temperature - Degrees Fahrenheit158.00-4.00

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A mains electricity (AC-powered) automatic cycling device intended to provide long-term alveolar ventilation support for the full age-range of patients, from neonatal, paediatric to adult, in a critical care setting. It typically uses positive pressure to deliver gas at normal breathing rates and tidal volumes through an endotracheal (ET) tube or tracheostomy, and consists of a breathing circuit, a control system, monitors, and alarms. The inhalation limb includes sites where inspired gas may be heated/humidified, and the exhalation limb includes an exhaust valve to release gas to the ambient air. It can be operated in several modes (e.g., assist/control, synchronized, patient triggered).