FDA device listing
Flexi Seal Air Bag,Flexi-Seal AIR (with ENFit Connector)
FDA device listing 1635474744 · ConvaTec
Key facts
| Proprietary names | Flexi Seal Air Bag,Flexi-Seal AIR (with ENFit Connector) |
|---|---|
| Owner/operator | ConvaTec |
| Owner/operator number | 2241599 |
| Premarket submissions | K243228 |
| Product codes | KNT, PIF |
| Device names | KNT - Tubes, Gastrointestinal (And Accessories), PIF - Gastrointestinal Tubes With Enteral Specific Connectors |
| Device class | Class II |
| Classification regulations (21 CFR) | 876.5980 |
| Review panels | Gastroenterology & Urology |
| Registered establishments | CONVATEC DOMINICAN REPUBLIC, INC., ConvaTec, Inc., ConvaTec Limited, GDC Building |
| Establishment registrations | 9618003, 3008806809, 3011987967 |
| FEI numbers | 3003264198, 3008806809, 3011987967 |
| Establishment operations | Complaint File Establishment, Foreign Exporter, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 10–99 UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes 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