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Sign in to claim this brandWhat Aerogen, Inc. makes
Aerogen, Inc. manufactures benchtop therapeutic agent nebulizers designed for continuous or intermittent nebulization of respiratory medications. Their portfolio includes standalone nebulizer systems and compatible consumable accessories, such as nebulization tubes. These devices are intended for use in clinical and homecare settings to deliver aerosolized treatments for respiratory conditions.
The company’s products are classified as Class II medical devices under FDA regulations and are listed in the FDA’s 510(k) and UDI databases. Aerogen, Inc. is headquartered in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Aerogen, Inc. manufacture?
Aerogen, Inc. specializes in benchtop therapeutic agent nebulizers, which are devices designed to aerosolize respiratory medications for inhalation therapy. Their portfolio includes standalone nebulizer systems like the Aerogen Solo and compatible consumables, such as nebulization tubes. These devices are intended for both clinical and homecare settings to deliver continuous or intermittent nebulized treatments for respiratory conditions.
Where is Aerogen, Inc. based, and what is its primary focus?
Aerogen, Inc. is headquartered in the United States. The company focuses on developing and manufacturing benchtop nebulizers, which are medical devices used to convert liquid medications into a fine mist for inhalation. Their products are tailored for delivering aerosolized therapies to patients with respiratory conditions.
Which regulatory registries list Aerogen, Inc.’s devices?
Aerogen, Inc.’s devices are listed in the FDA’s 510(k) premarket notification database and the FDA’s Unique Device Identifier (UDI) system. These registries track medical devices that have undergone the necessary regulatory pathways to demonstrate safety and effectiveness for their intended use.
How are Aerogen, Inc.’s devices classified under FDA regulations?
Aerogen, Inc.’s nebulizers are classified as Class II medical devices under FDA regulations. This classification applies to devices that generally pose moderate risk and require special controls—such as performance standards or post-market surveillance—to ensure their safety and effectiveness before they enter the market.
AI-generated from registry data and not verified by a human reviewer.
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Catalogue (138)
Page 2 of 3| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Aerogen® Solo Nebulizer System | 60-045 | FDA UDI | Class II | Unknown |
| Aerogen® Solo Nebulizer System | AG-AS3300-US | FDA UDI | Class II | Unknown |
| Aerogen® Solo Nebulizer System | AG-AS5000-PH | FDA UDI | Class II | Unknown |
| Aerogen® Solo Nebulizer System | AG-AS3035 | FDA UDI | Class II | Active |
| Aerogen® Solo; Aerogen Ultra | 90-214 | FDA UDI | Class II | Active |
| NIVO Nebulizer System | 1098093 | FDA UDI | Class II | Unknown |
| Aerogen® Solo Nebulizer System | 99-253 | FDA UDI | Class II | Unknown |
| Aerogen® USB Controller System | AG-UC7700-US | FDA UDI | Class II | Active |
| Aerogen® Professional Nebulizer System | AG-AP1500-US | FDA UDI | Class II | Unknown |
| Aerogen® Solo; Aerogen Ultra | AG-AS7501-US | FDA UDI | Class II | Active |
| Aerogen® Solo; Aerogen Ultra | AG-AS7700-US | FDA UDI | Class II | Active |
| NIVO Nebulizer System | 1079422 | FDA UDI | Class II | Unknown |
| Aerogen® Solo Nebulizer System | AG-AS3350-US | FDA UDI | Class II | Active |
| Aerogen® Professional Nebulizer System | 60-044 | FDA UDI | Class II | Active |
| Aerogen® Professional Nebulizer System | AG-AP1035 | FDA UDI | Class II | Unknown |
| Aerogen® Solo Nebulization System | AG-PX1000-US | FDA UDI | Class II | Unknown |
| Aerogen® Solo Nebulizer System | AG-AS3300-US | FDA UDI | Class II | Active |
| Aerogen® Solo Nebulizer System | AG-AS3001 | FDA UDI | Class II | Active |
| Aerogen® Solo Nebulizer System | AG-AS3500-US | FDA UDI | Class II | Active |
| Aerogen® Solo Nebulizer System | AG-AS4300-US | FDA UDI | Class II | Unknown |
| Aerogen Solo Nebulizer System | AG-AS3010-US | FDA UDI | Class II | Active |
| Aerogen® Solo Nebulizer System | AG-AS3600-US | FDA UDI | Class II | Unknown |
| Aerogen® USB Controller System | AG-UC1600-US | FDA UDI | Class II | Unknown |
| Aerogen® Solo Nebulizer System | 90-039 | FDA UDI | Class II | Active |
| Aerogen® Solo Nebulizer System | AG-AS3300 | FDA UDI | Class II | Unknown |
| Aerogen® Solo; Aerogen Ultra | 90-252 | FDA UDI | Class II | Active |
| Aerogen® Solo Nebulizer System | AG-AS3200-US | FDA UDI | Class II | Active |
| Aerogen® Solo Nebulizer System | AG-AS3036 | FDA UDI | Class II | Active |
| Aerogen® Solo Nebulizer System | 90-211 | FDA UDI | Class II | Unknown |
| Aerogen® USB Controller System | AG-UC1000-US | FDA UDI | Class II | Unknown |
| Aerogen® Solo; Aerogen Ultra | 90-213 | FDA UDI | Class II | Active |
| Aerogen® Solo Nebulizer System | 10-052 | FDA UDI | Class II | Active |
| Aerogen® Solo Nebulizer System | 10-047 | FDA UDI | Class II | Active |
| Aerogen® USB Controller System | AG-UC2000-US | FDA UDI | Class II | Unknown |
| NIVO Nebulizer System | 1082694 | FDA UDI | Class II | Unknown |
| Aerogen® USB Controller System | 80-014 | FDA UDI | Class II | Active |
| NIVO Nebulizer System | 1079421 | FDA UDI | Class II | Unknown |
| Aerogen® Solo Continuous Nebulization Tube Set | AG-AS3089-US | FDA UDI | Class II | Active |
| Aerogen® Solo; Aerogen Ultra | 90-205 | FDA UDI | Class II | Active |
| Aerogen® USB Controller System | AG-UC1500-US | FDA UDI | Class II | Active |
| NIVO Nebulizer System | 1082695 | FDA UDI | Class II | Unknown |
| Aerogen® USB Controller System | AG-UC1000-US | FDA UDI | Class II | Active |
| Aerogen® Solo Nebulizer System | 10-204 | FDA UDI | Class II | Active |
| Aerogen® Solo Nebulizer System | 10-355 | FDA UDI | Class II | Active |
| Aerogen® Solo; Aerogen Ultra | 90-212 | FDA UDI | Class II | Active |
| NIVO Nebulizer System | 90-067 | FDA UDI | Class II | Unknown |
| Aerogen® Solo; Aerogen Ultra | AG-AS7009-US | FDA UDI | Class II | Active |
| Aerogen® Professional Nebulizer System | AG-AP6000-US | FDA UDI | Class II | Unknown |
| Aerogen® Professional Nebulizer System | AG-AP1065 | FDA UDI | Class II | Unknown |
| Aerogen® Solo Nebulizer System | AG-AS3020 | FDA UDI | Class II | Active |
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