Bard® DigniShield® Stool Management System
Catalogue number SMS002, listed by C.R. Bard, Inc., United States, under Tubes, Gastrointestinal (And Accessories). 25 manufacturers in China are registered for this product code.
25manufacturers in China registered for this device type
1catalogue number
15510(k) clearances naming this product code
8recalls on this code
Who Else Makes It
Concentrated in Jiangsu (17), Zhejiang (4), Guangdong (2). 11 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amsino Medical (Kunshan) Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 53 |
| Jiangsu JianYu Health Medical Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 35 |
| Jabil Circuit (Shanghai) Ltd. | Shanghai | Shanghai | Contract manufacturer | 31 |
| Conod Medical Shuyang Co., Ltd. | Shuyang | Jiangsu | Contract manufacturer | 22 |
| Jiangsu Caina Medical Co., Ltd. | Jiangyin | Jiangsu | Contract manufacturer | 20 |
| Jiangsu Weikang Jiejing Medical Apparatus Co., Ltd. | Shuyang | Jiangsu | Contract manufacturer | 18 |
| Mcreat ( Guangzhou ) BIO-Tech Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 14 |
| Primecare Medical (Huzhou) Co., Ltd. | Hu Zhou | Zhejiang | Contract manufacturer | 9 |
| Yangzhou Xingwei Medical Technology Co., Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 5 |
| Tessy Plastics Shanghai Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 4 |
| Flexan (Suzhou) Precision Rubber Products Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 1 |
| Huzhou Junda Industry Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 129 |
Showing 12 of 25. All 25 manufacturers in China registered for Tubes, Gastrointestinal (And Accessories)
Record
| Listed by | C.R. Bard, Inc., United States |
|---|---|
| FDA product code | KNT |
| Device type | Tubes, Gastrointestinal (And Accessories) |
| 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 | 2016-08-25 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature up to 127 °F |
| Packaging | Case of 2 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SMS002 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Avanos | Avanos Medical, Inc. | 1,169 |
| Halyard | Avanos Medical, Inc. | 1,004 |
| G-Jet® Transgastric-Jejunal Feeding Device | Applied Medical Technology, Inc. | 376 |
| MiniONE Balloon Button | Applied Medical Technology, Inc. | 373 |
| Mini ONE® Balloon Button | Applied Medical Technology, Inc. | 336 |
| Kangaroo | Cardinal Health | 326 |
| NutraGlide Nasal Feeding Tube | Applied Medical Technology, Inc. | 279 |
| AMT Mini™ Balloon Button | Applied Medical Technology, Inc. | 231 |
| Vygon | Vygon Corp. | 229 |
| NeoDevices, Inc. | Neodevices Inc | 123 |
| Corflo cuBBy Lpgd | Corpak Medsystems | 98 |
| Kangaroo | Cardinal Health 200, LLC | 98 |
Showing 12 of 457. All products under Tubes, Gastrointestinal (And Accessories)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K253514 | 2026-07-10 |
| K133251 | 2014-05-09 |
| K102391 | 2010-12-22 |
| K103109 | 2010-12-22 |
| K073598 | 2008-06-13 |
| K063118 | 2007-02-13 |
| K033562 | 2003-12-12 |
| K013144 | 2001-10-19 |
| K991375 | 1999-09-10 |
| K946249 | 1995-12-11 |
| K915841 | 1993-06-25 |
| K915837 | 1993-03-23 |
| K890870 | 1989-04-27 |
| K890871 | 1989-04-27 |
| K843305 | 1984-10-11 |
Recalls
5 of these are Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. 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 |
|---|---|---|---|---|---|
| 2025-04-17 | Class I | Device Design | Due to customer complaints, there is a potential for users to be unable to or find it difficult to remove the plastic plugs in order to inflate the gastric and/or esophageal balloons. | ||
| 2025-04-17 | Class I | Device Design | Due to customer complaints, there is a potential for users to be unable to or find it difficult to remove the plastic plugs in order to inflate the gastric and/or esophageal balloons. | ||
| 2025-04-17 | Class I | Device Design | Due to customer complaints, there is a potential for users to be unable to or find it difficult to remove the plastic plugs in order to inflate the gastric and/or esophageal balloons. | ||
| 2025-04-17 | Class I | Device Design | Due to customer complaints, there is a potential for users to be unable to or find it difficult to remove the plastic plugs in order to inflate the gastric and/or esophageal balloons. | ||
| 2025-04-17 | Class I | Device Design | Due to customer complaints, there is a potential for users to be unable to or find it difficult to remove the plastic plugs in order to inflate the gastric and/or esophageal balloons. | ||
| 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. | 187550 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. | 133610 units | |
| 2010-10-28 | Not classified | Employee error | The product is misbranded. The product is labeled as 22 French, however the product is actually 20 French. | 108 eaches | 2011-03-31 |
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.