SiL Feeding Tube
SIL Feeding Tube Orange 6.5Fr 60cm
3manufacturers in China registered for this device type
9catalogue numbers in this listing
1recall
Who Else Makes It
Concentrated in Jiangsu (1), Zhejiang (1), Shandong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| ShanDong WeiGao Group Medical Polymer Co., Ltd. | Weihai | Shandong | Contract manufacturer | 3 |
| VR Medical Technology Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 13 |
| Ningbo Tianyi Medical Appliance Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 11 |
Record
| Listed by | Avanos Medical, Inc., United States |
|---|---|
| FDA product code | FPD |
| Device type | Tube, Feeding |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5980 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K072881 |
| Record published | 2021-04-23 |
| Record revised | 2023-06-22 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 16 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FTM8.0S-EO | In distribution | |
| FTL8.0S-EO | In distribution | |
| FTM6.5S-EO | In distribution | |
| FTL6.5S-EO | In distribution | |
| FTS6.5S-EO | In distribution | |
| FTS5.0S-EO | In distribution | |
| FTM5.0S-EO | In distribution | |
| FTL5.0S-EO | In distribution | |
| FTS8.0S-EO | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Vygon | Vygon Corp. | 236 |
| Ameritus | Kentec Medical, LLC | 83 |
| Avanos | Avanos Medical, Inc. | 51 |
| Halyard | Avanos Medical, Inc. | 50 |
| Ameritus ENFit | Kentec Medical, LLC | 38 |
| MED-RX | Canadian Hospital Specialties Ltd. | 28 |
| DeRoyal | Deroyal Industries, Inc. | 20 |
| ENFit SIL Feeding Tube | Avanos Medical, Inc. | 18 |
| NeoConnect Enteral Feeding Tube | Neomed Co., Ltd. | 18 |
| TubeClear | Actuated Medical, Inc. | 14 |
| Corflo Ultra Lite NG | Corpak Medsystems | 13 |
| Aquarius | Degania Silicone, Ltd. | 11 |
Showing 12 of 33. All products under Tube, Feeding
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2018-06-04 | Class II | Other | Potential for the tethered plug on the hub of the NeoMed Enteral Feeding Tubes with Enteral Only Connectors to inadvertently open after closure. | 208,260 units (20,826 cases) | 2020-07-21 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.