FDA device listing
ACCESSORY KIT (PEN,STAR,HEART),CABINET FILTER FOR OPTIUM,DRAWING BRD FOR NEB-A-DOODLE,FILTER CAP FOR NEB-A-DOODLE,FILTER…
FDA device listing 1185821652 · Zhongshan A&E Machinery Industry Co., LTD
Key facts
| Proprietary names | ACCESSORY KIT (PEN,STAR,HEART),CABINET FILTER FOR OPTIUM,DRAWING BRD FOR NEB-A-DOODLE,FILTER CAP FOR NEB-A-DOODLE,FILTER CAPS FOR EV NEB,FILTER CAPS NEB-U-TYKE TRAIN,FILTER FOR NEB PENGUIN & EV,FILTER PACK FOR NEB SPEEDSTER,FILTER PK FOR NEB-U-TYKE TRAIN,NEB-U-LITE EV 12/CS,NEBULIZER CUP EACH,NEB-U-TYKE IC - PENGUIN,NEB-U-TYKE IGLOO DISPLAY,NEB-U-TYKE NEB-A-DOODLE,NEB-U-TYKE RACETRACK… |
|---|---|
| Owner/operator | Zhongshan A&E Machinery Industry Co., LTD |
| Owner/operator number | 10049449 |
| Premarket submissions | K091272 |
| Product codes | CAF |
| Device names | CAF - Nebulizer (Direct Patient Interface) |
| Device class | Class II |
| Classification regulations (21 CFR) | 868.5630 |
| Review panels | Anesthesiology |
| Registered establishments | ZHONGSHAN A&E MACHINERY INDUSTRY CO., LTD |
| Establishment registrations | 3003781173 |
| FEI numbers | 3003781173 |
| Establishment operations | Foreign Exporter |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 100–999 UDI devices (GUDID) under the same submission
- 10–99 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database