Airlife™ Isothermal™ Breathing Circuit Pediatric Respiratory Circuit Heated
AirLife - 4253-H12
Device Description
A mechanical device designed to provide a visual indication of a patient's airway pressure during ventilation. It is typically contained in a clear housing marked with a pressure scale [e.g., 5 to 60 cm H20 (hPa)], and has a spring-loaded indicator that, in resistance to the expiratory flow of air, registers the airway pressure. It connects to the manometer port of a variety of ventilation devices such as a resuscitation bag, hyperinflation bag, continuous positive airway pressure (CPAP) mask, or a CPAP circuit. It may be used in a healthcare setting (including ambulatory) or in the home. This is a single-use device.
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: BZE
Device Name: Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
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: 868.5270
Third Party Flag: Y
Medical Specialty: AN
Device IdentifiersDevice Id: 50885403027923
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 10885403027925
Package Quantity: 20
Package Discontinue Date: 3/31/2022 12:00:00 AM
Package Status: Not in Commercial Distribution
Package Type: Case
Device Id: 10885403027925
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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