FDA device listing
Spigot Guard - Urine Collection Bag Drain Cap
FDA device listing 1114215952 · DEMETECH CORP.
Key facts
| Proprietary names | Spigot Guard - Urine Collection Bag Drain Cap |
|---|---|
| Owner/operator | DEMETECH CORP. |
| Owner/operator number | 9041973 |
| 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 | DEMETECH CORP. |
| Establishment registrations | 1064584 |
| FEI numbers | 3003063934 |
| Establishment operations | Complaint File Establishment, Manufacturer |
| 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