Aerogen® Solo Nebulization System

GUDID 05391517931648

Aerogen Pro-X Controller (US)

AEROGEN LIMITED

Nebulizing system, non-heated

• Primary Device ID: 05391517931648
• NIH Device Record Key: 33034fba-c863-4807-99bc-6036da2f5fd5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Aerogen® Solo Nebulization System
• Version Model Number: AG-PX1050-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: false
• 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
• Phone: +35391540400
• Email: info@aerogen.com

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05391517931648 [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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-16

On-Brand Devices [Aerogen® Solo Nebulization System]

• 05391517931648: Aerogen Pro-X Controller (US)
• 05391517930627: Aerogen Pro-X Controller Kit (US)
• 05391517937725: AG-PX1000-US