FDA device listing
Nipro SafeTouch II Safety AVF
FDA device listing 1268368564 · NIPRO CORPORATION
Key facts
| Proprietary names | Nipro SafeTouch II Safety AVF |
|---|---|
| Owner/operator | NIPRO CORPORATION |
| Owner/operator number | 8030375 |
| Premarket submissions | K032777 |
| Product codes | FOZ |
| Device names | FOZ - Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days |
| Device class | Class II |
| Classification regulations (21 CFR) | 880.5200 |
| Review panels | General Hospital |
| Registered establishments | NIPRO CORPORATION, NIPRO MEDICAL CORPORATION, Nipro (Thailand) Corporation Limited |
| Establishment registrations | 1056186, 8041145, 3000247873 |
| FEI numbers | 1000132332, 3000247873, 3002974635 |
| Establishment operations | Complaint File Establishment, Foreign Exporter, 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