FDA device listing
Filter Plasma Leukoreduced w/ Tubing - LPS2,Filter Plasma LPS2 w/TBG (EU) - LPS2E,Filter Plasma Set - LPS2KLE,Filter…
FDA device listing 2031599686 · Sotera Health LLC
Key facts
| Proprietary names | Filter Plasma Leukoreduced w/ Tubing - LPS2,Filter Plasma LPS2 w/TBG (EU) - LPS2E,Filter Plasma Set - LPS2KLE,Filter Platelet f/ 1 Unit w/TBG - PL1B,Filter Platelets 12 RD w/S Set - PXL12K,Filter Platelets 12 RD w/TBG - PXL12C,Filter Platelets 12 RD w/Y Set - PXL12Y,Filter Platelets 6 RD s/S Set - PL6KS,Filter Platelets 6 RD w/TBG - PL6T,Filter Platelets 6 RD w/Y Set - PL6YS,Filter platelets 8 RD… |
|---|---|
| Owner/operator | Sotera Health LLC |
| Owner/operator number | 10029425 |
| Product codes | CAK |
| Device names | CAK - Microfilter, Blood Transfusion |
| Device class | Class II |
| Classification regulations (21 CFR) | 880.5440 |
| Review panels | General Hospital |
| Registered establishments | Sterigenics U.S., LLC, Sterigenics US, LLC |
| Establishment registrations | 1526534, 2029275 |
| FEI numbers | 1526534, 1000306431 |
| 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