FDA device listing
Anti-Reflux Bag: 6206,BAG, URINARY DRAIN, VINYL LF ANIT-REFLUX CHAMBER/FLUTTER VALVE 2000 ML,BAG, URINARY DRAIN, VINYL…
FDA device listing 1025359929 · Sotera Health LLC
Key facts
| Proprietary names | Anti-Reflux Bag: 6206,BAG, URINARY DRAIN, VINYL LF ANIT-REFLUX CHAMBER/FLUTTER VALVE 2000 ML,BAG, URINARY DRAIN, VINYL LF ANIT-REFLUX W/FLUTTER VALVE 2000 ML,CURITY Drain Set: 30510,CURITY Drain Set: 6261,DRAINAGE BAG,Drainage Bag B: 3057,Drainage Bag B: 6208,Drain bag holder vinyl,Drainge Bag Set: 6300,Drainge Bag Set: 6308,Drainge Bag Set: 6308LL,Drainge Bag Set: 6310,Economy Drainage… |
|---|---|
| Owner/operator | Sotera Health LLC |
| Owner/operator number | 10029425 |
| Product codes | KNX |
| Device names | KNX - Collector, Urine, (And Accessories) For Indwelling Catheter |
| Device class | Class II |
| Classification regulations (21 CFR) | 876.5250 |
| Review panels | Gastroenterology & Urology |
| Registered establishments | Sterigenics Shanghai ETO Ltd., Sterigenics U.S., LLC, Sterigenics US LLC |
| Establishment registrations | 1061124, 2029015, 2029275, 3004111573, 3007007790 |
| FEI numbers | 1000160458, 1000306431, 1000512168, 3004111573, 3007007790 |
| 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