Aerogen® Solo Nebulizer System
GUDID 05391517933222
Aerogen Solo Adult T-Piece
AEROGEN LIMITED
Nebulizing system, non-heated| Primary Device ID | 05391517933222 |
| NIH Device Record Key | 4c059359-f8b2-4468-b953-adf9160c1fc4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Aerogen® Solo Nebulizer System |
| Version Model Number | 10-139 |
| 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 |
| info@aerogen.com | |
| Phone | +35391540400 |
| info@aerogen.com | |
| Phone | +35391540400 |
| info@aerogen.com | |
| Phone | +35391540400 |
| info@aerogen.com | |
| Phone | +35391540400 |
| info@aerogen.com | |
| Phone | +35391540400 |
| info@aerogen.com | |
| Phone | +35391540400 |
| info@aerogen.com | |
| Phone | +35391540400 |
| info@aerogen.com | |
| Phone | +35391540400 |
| info@aerogen.com | |
| Phone | +35391540400 |
| info@aerogen.com | |
| Phone | +35391540400 |
| info@aerogen.com | |
| Phone | +35391540400 |
| info@aerogen.com | |
| Phone | +35391540400 |
| info@aerogen.com | |
| Phone | +35391540400 |
| info@aerogen.com | |
| Phone | +35391540400 |
| info@aerogen.com | |
| Phone | +35391540400 |
| info@aerogen.com | |
| Phone | +35391540400 |
| info@aerogen.com | |
| Phone | +35391540400 |
| info@aerogen.com | |
| Phone | +35391540400 |
| info@aerogen.com | |
| Phone | +35391540400 |
| info@aerogen.com | |
| Phone | +35391540400 |
| info@aerogen.com | |
| Phone | +35391540400 |
| info@aerogen.com | |
| Phone | +35391540400 |
| 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 |
| 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 |
| 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 |
| 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 | 05391517933222 [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 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) |
Trademark Results [Aerogen]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 AEROGEN 85401215 not registered Dead/Abandoned |
Adams Golf IP, Ltd. 2011-08-18 |
 AEROGEN 76232170 not registered Dead/Abandoned |
AeroGen, Inc. 2001-03-28 |
 AEROGEN 76204914 not registered Dead/Abandoned |
ByData, Inc. 2001-02-05 |
 AEROGEN 76204913 2595836 Dead/Cancelled |
ByData, Inc. 2001-02-05 |
 AEROGEN 75221960 2459921 Live/Registered |
STAMFORD DEVICES LIMITED 1997-01-02 |
 AEROGEN 74130036 1737464 Dead/Cancelled |
ROBERT J. MATTHEWS CO. 1991-01-14 |
 AEROGEN 72291620 0876826 Dead/Expired |
MADISON CHEMICAL CORPORATION 1968-02-21 |
AEROGEN 72291620 0876826 Dead/Expired |
SYSTEMS GENERAL, INC. 1968-02-21 |
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