FDA device listing
Shiley Neonatal Tracheostomy Tube Cuffless,Shiley Neonatal Tracheostomy Tube with TaperGuard Cuff,Shiley Pediatric…
FDA device listing 1602313249 · MIDWEST STERILIZATION CORP.
Key facts
| Proprietary names | Shiley Neonatal Tracheostomy Tube Cuffless,Shiley Neonatal Tracheostomy Tube with TaperGuard Cuff,Shiley Pediatric Tracheostomy Tube Long Cuffless,Shiley Pediatric Tracheostomy Tube with TaperGuard Cuff |
|---|---|
| Owner/operator | MIDWEST STERILIZATION CORP. |
| Owner/operator number | 1928237 |
| 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 | MIDWEST STERILIZATION CORP. |
| Establishment registrations | 1928237 |
| FEI numbers | 1928237 |
| 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