FDA device listing
Biotronix Healthcare Gravity Enteral feeding Set with EnFit Connector,Biotronix Healthcare Pump Bag Set with EnFit…
FDA device listing 1208024196 · Biotronix Healthcare Industries Inc.
Key facts
| Proprietary names | Biotronix Healthcare Gravity Enteral feeding Set with EnFit Connector,Biotronix Healthcare Pump Bag Set with EnFit Connector,Biotronix Healthcare Pump Set with EnFit Connector |
|---|---|
| Owner/operator | Biotronix Healthcare Industries Inc. |
| Owner/operator number | 10043487 |
| Premarket submissions | K181276 |
| 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 | BIOTRONIX HEALTHCARE INDUSTRIES INC. |
| Establishment registrations | 3010131137 |
| FEI numbers | 3010131137 |
| Establishment operations | Repackager/Relabeler |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- 1–9 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