Airlife™ Misty Max 10™ Nebulizer With 7' (2.1 m) Female U/Connect
AirLife - 002446
Device Description
An assembly of devices intended to be used in the home and clinical settings to generate non-heated aerosolized medication/fluids for inhalation by a patient, typically to treat/manage a respiratory disorder [e.g., chronic obstructive pulmonary disease (COPD), cystic fibrosis (CF)]. It may be a benchtop or trolley-mounted assembly and includes an electrically-powered generator (ultrasonic and/or compressor jet type), a reservoir, and a nebulizing chamber where the nebulization of the medicine usually occurs. Disposable devices (e.g., tubing, mask, mouthpiece) are attached to the device for inhalation.
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: CAF
Device Name: Nebulizer (Direct Patient Interface)
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: 868.5630
Third Party Flag: N
Medical Specialty: AN
Device IdentifiersDevice Id: 50885403010956
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 10885403010958
Package Quantity: 50
Package Discontinue Date: 3/31/2022 12:00:00 AM
Package Status: Not in Commercial Distribution
Package Type: Case
Device Id: 10885403010958
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