Aerogen Solo Nebulizer System

GUDID 05391517935578

Aerogen Solo CNTS Kit

AEROGEN LIMITED

Benchtop nebulizer, non-heated

• Primary Device ID: 05391517935578
• NIH Device Record Key: e870af5c-e889-41d7-8b9e-59f1f8f03f0d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aerogen Solo Nebulizer System
• Version Model Number: AG-AS3080-US
• Company DUNS: 989510003
• Company Name: AEROGEN LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +35391540400
• Email: info@aerogen.com
• Phone: +35391540400
• Email: info@aerogen.com
• Phone: +35391540400
• Email: info@aerogen.com
• Phone: +35391540400
• Email: info@aerogen.com
• Phone: +35391540400
• Email: info@aerogen.com
• Phone: +35391540400
• Email: info@aerogen.com

Operating and Storage Conditions

• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 450 millibar and 1100 millibar
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 450 millibar and 1100 millibar
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 450 millibar and 1100 millibar
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 450 millibar and 1100 millibar
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 450 millibar and 1100 millibar
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -20 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 450 millibar and 1100 millibar
• Storage Environment Humidity: Between 15 Percent (%) Relative Humidity and 95 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	05391517935578 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K070642

FDA Product Code

• CAF: Nebulizer (Direct Patient Interface)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2022-06-10
• Device Publish Date: 2020-05-19

On-Brand Devices [Aerogen Solo Nebulizer System]

• 05391517935011: Aerogen Solo Nebulizer Kit US
• 05391517934311: Adult T-Piece Assembly
• 05391517935585: Aerogen Solo Adult T-Piece 22 mm
• 05391517935578: Aerogen Solo CNTS Kit
• 05391517935561: Aerogen Solo Nebulizer 5 Pack Assembly
• 05391517934304: Adult T-Piece (Trend)