Aerogen® Professional Nebulizer System

GUDID 05391517930740

Pro Nebulizer

AEROGEN LIMITED

Nebulizing system, non-heated

• Primary Device ID: 05391517930740
• NIH Device Record Key: 1502c35d-8537-4938-9ade-9696a7da0a08
• Commercial Distribution Discontinuation: 2018-09-24
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Aerogen® Professional Nebulizer System
• Version Model Number: AG-AP1000
• 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	05391517930740 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K021175

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® Professional Nebulizer System]

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• 05391517933710: Pro Pediatric T Piece 15 mm & Adapter Kit
• 05391517933376: Aerogen Pro T-Piece
• 05391517933154: Aerogen Pro Elbow Facemask 22m/22f
• 05391517933147: Aerogen Pro Elbow Facemask
• 05391517933130: Aerogen Pro Vented Elbow
• 05391517933116: Aerogen Pro Control Module Assembly (US)
• 05391517933109: Aerogen Pro 10mm T-Piece Neonate (PS) (P/N 10-203) and Plug (P/N 10-040) Assembly
• 05391517933093: T-Piece neonate (P/N 10-123) and Plug (P/N 10-040) Assembly
• 05391517933079: Aerogen Pro Connector
• 05391517933062: T-Piece, Ped/ Neo (Polysulphone) (Annealed) (P/N 10-057) and Plug (P/N 10-040) Assembly
• 05391517933055: Aerogen Pro T-Piece Plug Assembly
• 05391517933024: Aerogen Pro Nebulizer
• 05391517931938: Pro Pediatric T-Piece 10mm
• 05391517931488: Aerogen Pro Controller (US)
• 05391517931341: Aerogen Pro Control Module (US)
• 05391517931297: Aerogen Pro Mask Kit (US)
• 05391517930740: Pro Nebulizer
• 05391517930177: Pro Nebulizer & T-Piece
• 05391517930160: Pro Nebulizer & Pediatric T-Piece
• 05391517930108: Aerogen Pro Vented Elbow
• 05391517930085: Pro Pediatric T-Piece 12mm
• 05391517930061: Pro Pediatric Adapter Kit
• 05391517930047: Pro Pediatric T-Piece 15mm
• 05391517930030: Pro Adult T-Piece 22mm
• 05391517930016: Aerogen Pro Nebulizer System