VR Medical Feeding Tube and Enteral Feeding Extension Set (EFES)
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identity
- Device Name
- Enteral Feeding Tube EUDAMED
- Model / Reference
- VR1315090 EUDAMEDVR1416090 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 16959180796078 EUDAMED16959180797464 EUDAMED
- Basic UDI-DI
- B-16959180796078 EUDAMEDB-16959180797464 EUDAMED
- 510(k) Number
- K180236 FDA 510(k)
- FDA Product Code
- FPD FDA 510(k)
- EMDN Code
- G0199 ORO-OESOPHAGEAL TUBES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.5980 FDA 510(k)
- Regulation Number
- 876.5980 FDA 510(k)
- Market of Registration
- Germany EUDAMED
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
No
Measuring Function
Yes
Incorporates Medicinal Product
No
The VR Medical Feeding Tube and Enteral Feeding Extension Set (EFES) is a medical device classified as a Tube, Feeding, designed for enteral nutrition delivery. It provides a sterile pathway for administering liquid nutrients directly into the gastrointestinal tract, supporting patients requiring long-term or specialized feeding regimens. The device combines a feeding tube with an extension set to facilitate safe and efficient nutrient administration while minimizing contamination risk.
The EFES is supplied as a single-use, sterile device intended for use in clinical settings such as hospitals, nursing homes, or home healthcare environments. It adheres to regulatory standards including FDA 510K clearance and MDD compliance, ensuring safety and performance for enteral feeding applications. Available in multiple sizes and configurations (as referenced by the listed FEI numbers), the device is designed for compatibility with standard enteral feeding systems and is non-magnetic, allowing safe use in MRI environments when appropriate precautions are followed. Storage instructions specify maintaining sterility until use.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K180236 | Class II | Active |
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Manufacturer
- Manufacturer
- VR Medical Technology Co., Ltd.
Sources (3)
- FDA 510(k) K180236 24 fields · synced Oct 7, 2026
- EUDAMED 4f599ea4-8370-4856-80e0-0a42bd59d271 61 fields · synced Jul 8, 2026
- EUDAMED d11dce63-40c3-47ce-a8fa-66fe0fa29376 61 fields · synced Jul 8, 2026