Bard® Adult/Pediatric Feeding Tube
Catalogue number 0036420, listed by C.R. Bard, Inc., United States, under Tube, Feeding. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
1catalogue number
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 | C.R. Bard, 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, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-08-16 |
| Record revised | 2022-06-30 (version 3) |
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 | Box of 50, case of 4 |
| Sizes | Catheter gauge 8 Fr; length 42 in |
| Distribution end date | 2020-03-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 0036420 | Catheter Gauge 8 Fr | Withdrawn |
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
4 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 |
|---|---|---|---|---|---|
| 2018-02-27 | Class II | Finished device change control | BMD has identified that the product code/lot number combination identified above may have ineffectively fused tubing and ENFit(TM) connector. | 3200 units | 2019-07-11 |
| 2018-02-27 | Class II | Finished device change control | BMD has identified that the product code/lot number combination identified above may have ineffectively fused tubing and ENFit(TM) connector. | 42200 units | 2019-07-11 |
| 2018-02-27 | Class II | Finished device change control | BMD has identified that the product code/lot number combination identified above may have ineffectively fused tubing and ENFit(TM) connector. | 4800 units | 2019-07-11 |
| 2018-02-27 | Class II | Finished device change control | BMD has identified that the product code/lot number combination identified above may have ineffectively fused tubing and ENFit(TM) connector. | 23400 units | 2019-07-11 |
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.