Aerogen ®Pro-X1 System IFU
Catalogue number AG-PX1187-US, listed by Aerogen Ltd, Ireland, under Ventilator-Compatible Nebulizer. 1 manufacturer in China is registered for this product code.
1manufacturer
1catalogue number
1510(k) clearance
Who Else Makes It
Registered in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Feellife Health Inc. | Shenzhen | Guangdong | Contract manufacturer | 8 |
Record
| Listed by | Aerogen Ltd, Ireland |
|---|---|
| FDA product code | SFP |
| Device type | Ventilator-Compatible Nebulizer |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5630 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K251615 |
| Record published | 2026-06-16 |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| Storage | Storage environment temperature -20 to 60 °C; Storage environment atmospheric pressure 450 to 1100 millibar; Storage environment atmospheric pressure 15 to 95 % RH |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AG-PX1187-US | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Aerogen® Pro-X1 Flow Sensor | Aerogen Ltd | 1 |
| Aerogen® Pro-X1 Sync Cable | Aerogen Ltd | 1 |
| Aerogen ® Pro-X1 Battery | Aerogen Ltd | 1 |
| Aerogen ® Pro-X1 AC/DC Adapter | Aerogen Ltd | 1 |
| Aerogen® Pro-X1 Controller System | Aerogen Ltd | 1 |
| Aerogen® Pro-X1 Nebuliser Cable | Aerogen Ltd | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K251615 | 2025-09-02 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.