FDA device listing
2008 Series 8 mm Home Hemodialysis with Prime Bag,COMBI SET®,Fresenius BVM Hemodialysis Blood Tubing Set with Priming…
FDA device listing 2048066766 · Sotera Health LLC
Key facts
| Proprietary names | 2008 Series 8 mm Home Hemodialysis with Prime Bag,COMBI SET®,Fresenius BVM Hemodialysis Blood Tubing Set with Priming Set |
|---|---|
| Owner/operator | Sotera Health LLC |
| Owner/operator number | 10029425 |
| Product codes | ODX, ONW |
| Device names | ODX - Autonomous Extracorporeal Blood Leak Detector/Alarm, ONW - Hemodialysis System For Home Use |
| Device class | Class II |
| Classification regulations (21 CFR) | 876.5820, 876.5860 |
| Review panels | Gastroenterology & Urology |
| Registered establishments | Sterigenics Radiation Technologies Canada, Inc, Sterigenics US LLC |
| Establishment registrations | 9680579, 3004111573 |
| FEI numbers | 1000203464, 3004111573 |
| Establishment operations | Contract Sterilizer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed 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