Airlife™ Isothermal™ Breathing Circuit Pediatric Inspiratory Line Heated

Airlife™ Isothermal™ Breathing Circuit Pediatric Inspiratory Line Heated
AirLife - 7331-HS5

An assembly of devices intended to be used in the home and clinical settings to generate warmed aerosolized medication/fluids (e.g., pharmacological drugs, medical cannabis) for inhalation by a patient, typically to treat/manage a respiratory disorder [e.g., chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF)] or various other conditions (e.g., chronic pain). It typically consists of a benchtop assembly with an electrically-powered generator, a reservoir, a heating element, dosing capsules, and a hand-held nebulizing/inhalation compartment (e.g., inflatable balloon with mouthpiece).

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

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 Id: 50885403039803

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 10885403039805

Package Quantity: 20

Package Discontinue Date: 3/31/2022 12:00:00 AM

Package Status: Not in Commercial Distribution

Package Type: Case

Device Id: 10885403039805

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