MED-RX
Feeding Tube Extension SET, Enteral Only, Standard Bore, FOR Pediatric USE
3manufacturers in China registered for this device type
28catalogue numbers in this listing
4recalls 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 | Canadian Hospital Specialties Ltd., Canada |
|---|---|
| FDA product code | FPD |
| Device type | Tube, Feeding |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5980 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer, Exporter |
| 510(k) | K100700 |
| Record published | 2021-03-29 |
| Record revised | 2024-03-18 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Corrugate case of 10, corrugate case of 100, corrugate case of 50, case of 100, corrugte case of 10, pack of 50 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 54-1042R | In distribution | |
| 54-5115R | In distribution | |
| 54-1680R | In distribution | |
| 54-7073 | In distribution | |
| 54-1650R | In distribution | |
| 54-3680R | In distribution | |
| 54-2480R | In distribution | |
| 54-1665R | In distribution | |
| 54-7063 | In distribution | |
| 54-2450R | In distribution | |
| 54-7069 | In distribution | |
| 54-5136R | In distribution | |
| YM54-7066 | In distribution | |
| 54-7050 | In distribution | |
| 54-7074 | In distribution | |
| 54-8115R | In distribution | |
| 54-6115R | In distribution | |
| 54-2440R | In distribution | |
| 54-6136R | In distribution | |
| 54-1204 | In distribution | |
| 54-8142R | In distribution | |
| 54-3665R | In distribution | |
| 54-7059 | In distribution | |
| 54-3650R | In distribution | |
| 54-7062 | In distribution | |
| 54-2465R | In distribution | |
| 54-1640R | In distribution | |
| 54-7066 | 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 |
| 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 |
| NeoMed Enteral Feeding Tube | Neomed Co., Ltd. | 11 |
Showing 12 of 33. All products under Tube, Feeding
Recalls Naming This Product
6 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Deroyal Industries, Inc. | 510(k) number | 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 |
| Canadian Hospital Specialties Ltd. | 510(k) number | 2019-07-16 | Class II | Under Investigation by firm | The firm received a complaint that the connector detached from the feeding tube. | 2870 units | 2025-05-28 |
| Deroyal Industries, Inc. | 510(k) number | 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 |
| Canadian Hospital Specialties Ltd. | 510(k) number | 2018-12-01 | Class II | Under Investigation by firm | The product may be packaged with a 5FR X 24 length Feeding tube instead of a 6.5 FR X 24 Feeding tube as labeled. | 75 cases of 10 | 2021-04-02 |
| Canadian Hospital Specialties Ltd. | 510(k) number | 2018-06-11 | Class II | Process control | The product may be packaged with the incorrect length of feeding tube as labeled. | 10/10-tube cases | 2019-03-13 |
| Canadian Hospital Specialties Ltd. | 510(k) number | 2015-12-11 | Class II | Under Investigation by firm | The product may be packaged with a 5 or 6.5FR tube instead of an 8FR size. | 120 units | 2016-10-31 |
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.