Bard® PreVent® Anti-Reflux Filter With ENFit™
Catalogue number EN0046000, listed by C.R. Bard, Inc., United States, under Tube, Double Lumen For Intestinal Decompression And/Or Intubation. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
10recalls on this code
Who Else Makes It
Concentrated in Guangdong (1), Jiangsu (1), Zhejiang (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jiangsu Caina Medical Co., Ltd. | Jiangyin | Jiangsu | Contract manufacturer | 20 |
| Well Lead Medical Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 46 |
| Ningbo Tianyi Medical Appliance Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 11 |
Record
| Listed by | C.R. Bard, Inc., United States |
|---|---|
| FDA product code | FEG |
| Device type | Tube, Double Lumen For Intestinal Decompression And/Or Intubation |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5980 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2016-09-19 |
| Record revised | 2024-11-06 (version 3) |
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 100, box of 10 |
| Distribution end date | 2024-02-29 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| EN0046000 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Salem Sump | Cardinal Health 200, LLC | 30 |
| Salem Sump | Cardinal Health | 18 |
| Bard® Nasogastric Sump Tube with PreVent® Anti-Reflux Filter | C.R. Bard, Inc. | 14 |
| Axiom® Dual-Sump | Axiom Medical, Inc. | 9 |
| Cardinal Health | Cardinal Health 200, LLC | 7 |
| Axiom® Uni-Sump | Axiom Medical, Inc. | 7 |
| Bard® Nasogastric Sump Tube and PreVent® Filter and Lopez Valve® with ENFit™ | C.R. Bard, Inc. | 6 |
| Bilbao Dotter | Cook Incorporated | 4 |
| Nasogastric Sump Tube with PreVent® Anti-Reflux Filter And Lopez Valve® | C.R. Bard, Inc. | 4 |
| Kangaroo | Cardinal Health | 3 |
| Marcon | Cook Ireland Ltd | 3 |
| Axiom® Sump-n-Sheath® | Axiom Medical, Inc. | 3 |
Showing 12 of 24. All products under Tube, Double Lumen For Intestinal Decompression And/Or Intubation
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K960176 | 1996-07-24 |
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| C.R. Bard, Inc. | UDI-DI | 2023-12-20 | Class II | Under Investigation by firm | BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred. | 39430 units |
Recalls
9 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 |
|---|---|---|---|---|
| 2023-12-20 | Class II | Under Investigation by firm | BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred. | 51750 units |
| 2023-12-20 | Class II | Under Investigation by firm | BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred. | 9860 units |
| 2023-12-20 | Class II | Under Investigation by firm | BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred. | 3360 units |
| 2023-12-20 | Class II | Under Investigation by firm | BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred. | 8010 units |
| 2023-12-20 | Class II | Under Investigation by firm | BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred. | 3650 units |
| 2023-12-20 | Class II | Under Investigation by firm | BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred. | 6600 units |
| 2023-12-20 | Class II | Under Investigation by firm | BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred. | 36440 units |
| 2023-12-20 | Class II | Under Investigation by firm | BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred. | 26100 units |
| 2023-12-20 | Class II | Under Investigation by firm | BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred. | 57159 units |
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.