FDA device listing
Closed System Transfer Device
FDA device listing 1921768795 · Shandong Ande Healthcare Apparatus Co., Ltd.
Key facts
| Proprietary names | Closed System Transfer Device |
|---|---|
| Owner/operator | Shandong Ande Healthcare Apparatus Co., Ltd. |
| Owner/operator number | 10056160 |
| Premarket submissions | K201460 |
| Product codes | ONB |
| Device names | ONB - Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System |
| Device class | Class II |
| Classification regulations (21 CFR) | 880.5440 |
| Review panels | General Hospital |
| Registered establishments | Shandong Ande Healthcare Apparatus Co., Ltd. |
| Establishment registrations | 3012039263 |
| FEI numbers | 3012039263 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None UDI devices (GUDID) under the same submission
- 1–9 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