FDA device listing
COMBI SET®,Priming Set for Arterial Bloodlines, with Needleless Access Port,Priming SetFor Hemodialysis,VENOFER…
FDA device listing 1805285423 · Sotera Health LLC
Key facts
| Proprietary names | COMBI SET®,Priming Set for Arterial Bloodlines, with Needleless Access Port,Priming SetFor Hemodialysis,VENOFER Fresenius Priming Set with Needle-less Access Port |
|---|---|
| Owner/operator | Sotera Health LLC |
| Owner/operator number | 10029425 |
| Product codes | KOC |
| Device names | KOC - Accessories, Blood Circuit, Hemodialysis |
| Device class | Class II |
| Classification regulations (21 CFR) | 876.5820 |
| Review panels | Gastroenterology & Urology |
| Registered establishments | Sterigenics Radiation Technologies Canada, Inc, Sterigenics US LLC |
| Establishment registrations | 1649518, 9680579, 3004111573 |
| FEI numbers | 1000203464, 3001236277, 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