FDA device listing
CAPD SAFE-LOCK 8 CATHETER EXTENSION SET WITH MALE AND FEMALE CONNECTOR,CAPD SAFE-LOCK® 8 CATHETER EXTENSION SET WITH…
FDA device listing 1291176879 · Sotera Health LLC
Key facts
| Proprietary names | CAPD SAFE-LOCK 8 CATHETER EXTENSION SET WITH MALE AND FEMALE CONNECTOR,CAPD SAFE-LOCK® 8 CATHETER EXTENSION SET WITH MALE AND FEMALE CONNECTOR AND ROLLER CLAMP,CAPD SAFE-LOCK® TRANSFER SET (48),Safe-Lock®,SAFE-LOCK® 4 CONVERTIBLE EXTENSION SET WITH MALE LUER LOCK AND FEMALE SAFE-LOCK CONNECTOR,Safe-Lock ® 6 Convertible Extension Set with Female Safe-Lock Connector Male Luer-Lock and Roller… |
|---|---|
| Owner/operator | Sotera Health LLC |
| Owner/operator number | 10029425 |
| Product codes | FKX |
| Device names | FKX - System, Peritoneal, Automatic Delivery |
| Device class | Class II |
| Classification regulations (21 CFR) | 876.5630 |
| 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