Airlife™ Isothermal™ Breathing Circuit Accessory
AirLife - 6073-504
Device Description
A non-powered small connecting device, which includes an integrated nebulizer, intended to join a sterile water or sterile isotonic sodium chloride solution reservoir to a respiratory gas source (typically wall outlet) and a gas administration device (e.g., mask, mouthpiece). It is designed to generate aerosolized fluid (finely dispersed airborne droplets in a liquid phase) to be inhaled by a patient with a respiratory disorder [e.g., chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF)]. 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: 50885403168640
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 10885403168642
Package Quantity: 30
Package Discontinue Date: 3/31/2022 12:00:00 AM
Package Status: Not in Commercial Distribution
Package Type: Case
Device Id: 10885403168642
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