Aerogen® Solo Nebulizer System

GUDID 05391517933314

Aerogen Solo Nebulizer

AEROGEN LIMITED

Nebulizing system, non-heated

• Primary Device ID: 05391517933314
• NIH Device Record Key: b0039b64-fcbd-4604-a613-e6657e6c098f
• Commercial Distribution Discontinuation: 2017-03-14
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Aerogen® Solo Nebulizer System
• Version Model Number: 99-253
• Company DUNS: 989510003
• Company Name: AEROGEN LIMITED
• Device Count: 40
• 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
• 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	00000000000000 [Unit of Use]
GS1	05391517933314 [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: 2017-02-23

On-Brand Devices [Aerogen® Solo Nebulizer System]

• 05391517933857: Aerogen Solo Nebuliser
• 05391517933765: Adult T-Piece Polycarbonate (Longford T&P)
• 05391517933758: Adult T-Piece Assembly (Longford T&P)
• 05391517933673: Aerogen Solo Nebulizer (25 Pack - US)
• 05391517933611: Aerogen Solo Elbow Facemask
• 05391517933604: Aerogen Solo Vented Elbow
• 05391517933598: Aerogen Solo Connector
• 05391517933581: Aerogen Solo Connector
• 05391517933352: Aerogen Pro-X Control Module (INT)
• 05391517933314: Aerogen Solo Nebulizer
• 05391517933253: Aerogen Solo Pediatric T-Piece 10mm
• 05391517933246: Aerogen Solo Pediatric T Piece 12mm
• 05391517933239: Aerogen Solo Pediatric T-Piece
• 05391517933222: Aerogen Solo Adult T-Piece
• 05391517933215: Aerogen Solo T-Piece Plug Assembly
• 05391517933208: Aerogen Pro-X Control Module USA
• 05391517933192: Aerogen Solo Nebulizer II Pouched
• 05391517933000: Aerogen Solo OR Convenience Kit (5 Pack)
• 05391517932966: Aerogen Solo Nebulizer Kit
• 05391517932522: Aerogen Solo Nebulizer
• 05391517932515: Aerogen Solo Nebulizer (10 Pack-US)
• 05391517932508: Aerogen Solo Nebulizer (5 Pack-US)
• 05391517931945: Solo Pediatric T Piece 10mm
• 05391517931914: Solo Vented Elbow
• 05391517931907: Solo Mask Kit (US)
• 05391517930610: Aerogen Solo Convenience Kit (10 Pack)
• 05391517930603: Aerogen Solo Convenience Kit (5 Pack)
• 05391517930399: Aerogen Solo Nebuliser
• 05391517930306: Solo Convenience Kit (5 Pack)
• 05391517930290: Solo Convenience Kit (10 Pack)
• 05391517930283: Solo Pediatric T-Piece 12mm
• 05391517930276: Solo Pediatric T-Piece Adapter Kit
• 05391517930269: Solo Pediatric T-Piece 15mm
• 05391517930252: Solo Adult T-Piece 22mm
• 05391517930245: Solo Nebuliser (10 Pack)
• 05391517930238: Solo Nebuliser (5 Pack)
• 05391517930221: Aerogen Solo Starter Kit (US)
• 05391517934021: T-Piece Ped/Neo (PC)
• 05391517936193: Aerogen Controller Longer Cable (2.5M)
• 05391517936223: Pouched Solo II Assembly (Top Seal)
• 05391517937466: Aerogen Solo Convenience Kit (5 pack)