DeRoyal
Enteral Safe Extension Set 62"
3manufacturers in China registered for this device type
20catalogue numbers in this listing
2recalls on this code
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 | Deroyal Industries, Inc., United States |
|---|---|
| FDA product code | FPD |
| Device type | Tube, Feeding |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5980 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Record published | 2016-09-12 |
| Record revised | 2021-07-23 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 10, case of 100, case of 50 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 54-1680R | In distribution | |
| 54-3650R | In distribution | |
| 54-7069 | In distribution | |
| 54-2465R | In distribution | |
| 54-7066 | In distribution | |
| 54-3680R | In distribution | |
| 54-6136R | In distribution | |
| 54-5136R | In distribution | |
| 54-6115R | In distribution | |
| 54-5115R | In distribution | |
| 54-8142R | In distribution | |
| 54-1640R | In distribution | |
| 54-7062 | In distribution | |
| 54-2440R | In distribution | |
| 54-1650R | In distribution | |
| 54-8115R | In distribution | |
| 54-3665R | In distribution | |
| 54-2450R | In distribution | |
| 54-2480R | In distribution | |
| 54-1665R | 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 |
| 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 |
| NeoMed Enteral Feeding Tube | Neomed Co., Ltd. | 11 |
Showing 12 of 33. All products under Tube, Feeding
Recalls
2 of these are 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 |
|---|---|---|---|---|---|
| 2019-07-22 | Class II | Nonconforming Material/Component | Certain MED-RX Polyurethane Feeding Tubes are being recalled due to a product concern where the connector has detached from the feeding tube. | 180 cases of 10 units | 2020-12-14 |
| 2018-12-17 | Class II | Under Investigation by firm | Enteral Safe Feeding Tubes labeled as 6.5 FR X 24″ contained 5 FR X 24″ Enteral Safe Feeding Tubes. | 200 units | 2020-12-16 |
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.