FDA device listing
Nipro Set - SLIMLINE Blood Tubing Set with Transducer Protector and Priming Set
FDA device listing 1190582556 · NIPRO CORPORATION
Key facts
| Proprietary names | Nipro Set - SLIMLINE Blood Tubing Set with Transducer Protector and Priming Set |
|---|---|
| Owner/operator | NIPRO CORPORATION |
| Owner/operator number | 8030375 |
| Premarket submissions | K112628 |
| Product codes | FJK |
| Device names | FJK - Set, Tubing, Blood, With And Without Anti-Regurgitation Valve |
| Device class | Class II |
| Classification regulations (21 CFR) | 876.5820 |
| Review panels | Gastroenterology & Urology |
| Registered establishments | NIPRO CORPORATION, NIPRO MEDICAL CORPORATION, Nipro (Thailand) Corporation Limited, PT. Nipro Indonesia Jaya |
| Establishment registrations | 1056186, 8041145, 3000247873, 3010377171 |
| FEI numbers | 1000132332, 3000247873, 3002974635, 3010377171 |
| Establishment operations | Complaint File Establishment, Foreign Exporter, Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 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