Aerogen® USB Controller System

GUDID 05391517931310

Aerogen Pro USB Controller Starter Kit (US)

AEROGEN LIMITED

Nebulizing system, non-heated

• Primary Device ID: 05391517931310
• NIH Device Record Key: a6e139df-0af0-4a42-8c4b-a77ccbefee4d
• Commercial Distribution Discontinuation: 2018-09-24
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Aerogen® USB Controller System
• Version Model Number: AG-UC1600-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 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 450 millibar and 1060 millibar
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 450 millibar and 1060 millibar
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 450 millibar and 1060 millibar
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 450 millibar and 1060 millibar
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 450 millibar and 1060 millibar
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 450 millibar and 1060 millibar
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius
• Storage Environment Humidity: Between 0 Percent (%) Relative Humidity and 93 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 450 millibar and 1060 millibar
• Storage Environment Temperature: Between -25 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05391517931310 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143719

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: 4
• Public Version Date: 2018-09-24
• Device Publish Date: 2016-09-16

On-Brand Devices [Aerogen® USB Controller System]

• 05391517933369: Aerogen USB Controller (US)
• 05391517932997: Aerogen USB Controller Bundle
• 05391517932973: Replacement Aerogen USB Controller, US
• 05391517931310: Aerogen Pro USB Controller Starter Kit (US)
• 05391517930566: Aerogen USB Controller (US)
• 05391517930542: Aerogen Solo USB Controller Starter Kit (US)
• 05391517935035: Aerogen Solo USB Controller Starter Kit
• 05391517937732: AG-UC1000-US