FDA device listing
Arrow® Pressure Injectable Multi-Lumen PICC Set,Arrow® Pressure Injectable PICC Kit with Blue FlexTip®,Arrow® Pressure…
FDA device listing 1521214199 · Sotera Health LLC
Key facts
| Proprietary names | Arrow® Pressure Injectable Multi-Lumen PICC Set,Arrow® Pressure Injectable PICC Kit with Blue FlexTip®,Arrow® Pressure Injectable PICC Kit with Blue FlexTip® Catheter,Arrow® Pressure Injectable PICC Set with Blue FlexTip® Catheter,Arrow® Pressure Injectable Two-Lumen PICC Kit,Arrow® Pressure Injectable Two-Lumen PICC Kit with Blue FlexTip® Catheter,Arrow® Pressure Injectable Two-Lumen PICC… |
|---|---|
| Owner/operator | Sotera Health LLC |
| Owner/operator number | 10029425 |
| Product codes | LJS |
| Device names | LJS - Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days |
| Device class | Class II |
| Classification regulations (21 CFR) | 880.5970 |
| Review panels | General Hospital |
| Registered establishments | Sterigenics U.S., LLC |
| Establishment registrations | 1061124 |
| FEI numbers | 1000512168 |
| 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