FDA device listing
Salem Sump Silicone Dual Lumen Stomach Tube with ENFit Connection
FDA device listing 1561479747 · WELL LEAD MEDICAL CO. LTD
Key facts
| Proprietary names | Salem Sump Silicone Dual Lumen Stomach Tube with ENFit Connection |
|---|---|
| Owner/operator | WELL LEAD MEDICAL CO. LTD |
| Owner/operator number | 9045441 |
| Product codes | FEG, PIF |
| Device names | FEG - Tube, Double Lumen For Intestinal Decompression And/Or Intubation, PIF - Gastrointestinal Tubes With Enteral Specific Connectors |
| Device class | Class II |
| Classification regulations (21 CFR) | 876.5980 |
| Review panels | Gastroenterology & Urology |
| Registered establishments | WELL LEAD MEDICAL CO. LTD |
| Establishment registrations | 3003903031, 3010400865 |
| FEI numbers | 3003903031, 3010400865 |
| Establishment operations | Contract Manufacturer, 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