FDA device listing
IN CAN PER-FIT 6.0MM (FOR 7.0MM TUBE) + 20/CA Portex Per-Fit Percutaneous Tracheostomy Inner Cannula,IN CAN PER-FIT…
FDA device listing 1003684073 · Sotera Health LLC
Key facts
| Proprietary names | IN CAN PER-FIT 6.0MM (FOR 7.0MM TUBE) + 20/CA Portex Per-Fit Percutaneous Tracheostomy Inner Cannula,IN CAN PER-FIT 8.0MM (FOR 9.0MM TUBE) + 20/CA Portex Per-Fit Percutaneous Tracheostomy Inner Cannula,K031057,TRACHEOSTOMY PER-FIT KIT 7.0MM + 2/CA Portex Per-Fit Percutaneous Tracheostomy Kit,TRACHEOSTOMY PER-FIT KIT 8.0MM + 2/CA Portex Per-Fit Percutaneous Tracheostomy Kit,TRACHEOSTOMY PER-FIT KIT… |
|---|---|
| Owner/operator | Sotera Health LLC |
| Owner/operator number | 10029425 |
| Product codes | JOH |
| Device names | JOH - Tube Tracheostomy And Tube Cuff |
| Device class | Class II |
| Classification regulations (21 CFR) | 868.5800 |
| Review panels | Anesthesiology |
| Registered establishments | Sterigenics U.S., LLC |
| Establishment registrations | 1319639 |
| FEI numbers | 1000138054 |
| 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