Bardia® Complete Foley Kit
Bardia® Complete Foley Kit with Silicone Elastomer Coated Foley Catheter
9manufacturers in China registered for this device type
2catalogue numbers in this listing
10510(k) clearances naming this product code
14recalls on this code
Who Else Makes It
Concentrated in Jiangsu (3), Zhejiang (3), Guangdong (2). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Well Lead Medical Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 46 |
| Suzhou Jingle Polymer Medical Apparatus Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Guangdong Ecan Medical Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 14 |
| Clinisupplies (Nanjing) Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 13 |
| Integral Medical Products Co., Ltd. | Shaoxing | Zhejiang | Contract manufacturer | 7 |
| Hangzhou Jimushi Meditech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 6 |
| Sterigenics Shanghai ETO Ltd. | Shanghai | Shanghai | Contract manufacturer | 65 |
| Steris Sterilization Technologies (Suzhou) Ltd | Suzhou | Jiangsu | Contract manufacturer | 44 |
| Integral Sterilization Technology (Shaoxing) Co., Ltd. | Shaoxing | Zhejiang | Contract manufacturer | 5 |
Record
| Listed by | C.R. Bard, Inc., United States |
|---|---|
| FDA product code | KOD |
| Device type | Catheter, Urological |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5130 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2016-06-13 |
| Record revised | 2020-12-04 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 10 |
| Sizes | Catheter gauge 16 to 18 Fr |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 800316 | Catheter Gauge 16 Fr | In distribution |
| 800318 | Catheter Gauge 18 Fr | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Rusch | Teleflex Medical LLC | 432 |
| Dover | Cardinal Health 200, LLC | 163 |
| Dover | Cardinal Health | 152 |
| MTG | HR Pharmaceuticals Inc. | 59 |
| Cook | Cook Incorporated | 43 |
| Bardex® Lubricath® Foley Catheter | C.R. Bard, Inc. | 30 |
| Magic3™ Intermittent Catheter | C.R. Bard, Inc. | 30 |
| Ureteral Catheter | Well Lead Medical Co., Ltd. | 26 |
| Bardex® Urethral Catheter Robinson Model | C.R. Bard, Inc. | 26 |
| Personal Catheter™ Intermittent Catheter | C.R. Bard, Inc. | 24 |
| DeRoyal | Deroyal Industries, Inc. | 23 |
| Bard® Robinson Catheter | C.R. Bard, Inc. | 22 |
Showing 12 of 150. All products under Catheter, Urological
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K251864 | 2026-02-23 |
| K033719 | 2004-02-04 |
| K922527 | 1994-04-14 |
| K922431 | 1993-03-25 |
| K900229 | 1990-04-17 |
| K834438 | 1984-02-04 |
| K821745 | 1982-06-24 |
| K821272 | 1982-06-22 |
| K791717 | 1979-09-17 |
| K770814 | 1977-10-18 |
Recalls
12 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 |
|---|---|---|---|---|---|
| 2026-06-25 | Not classified | Under Investigation by firm | Due to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent Catheter Trays. | 391720 units/kits | |
| 2025-06-03 | Class II | Under Investigation by firm | Cather packaging may contain the incorrect French size. | ||
| 2025-06-03 | Class II | Under Investigation by firm | Cather packaging may contain the incorrect French size. | ||
| 2022-01-27 | Class II | Under Investigation by firm | There is a potential to leak from the catheter where it connects to the drain bag | 1620 units | 2026-07-10 |
| 2022-01-27 | Class II | Under Investigation by firm | There is a potential to leak from the catheter where it connects to the drain bag | 2120 units | 2026-07-10 |
| 2021-01-11 | Class II | Packaging process control | The device catheter tip was cut off (no tip) and the product packaging was not fully sealed. | 9,800 Units | 2023-02-02 |
| 2015-08-24 | Class II | Unknown/Undetermined by firm | Potential breach of the sterile barrier packaging. | 8,970 each | 2016-08-01 |
| 2015-07-07 | Class II | Unknown/Undetermined by firm | Potential breach of the sterile barrier packaging. | 37,686 each | 2017-07-21 |
| 2015-07-07 | Class II | Unknown/Undetermined by firm | Potential breach of the sterile barrier packaging. | 14,310 each | 2017-07-21 |
| 2015-07-07 | Class II | Unknown/Undetermined by firm | Potential breach of the sterile barrier packaging. | 534,972 each | 2017-07-21 |
| 2015-07-07 | Class II | Unknown/Undetermined by firm | Potential breach of the sterile barrier packaging. | 91,140 each | 2017-07-21 |
| 2015-07-07 | Class II | Unknown/Undetermined by firm | Potential breach of the sterile barrier packaging. | 16,799 each | 2017-07-21 |
| 2012-09-07 | Class II | Employee error | The 8 Fr. Bardex All-Silicone Foley Catheter with 3cc balloon had an incorrect inflation volume (10 ml instead of 5 ml) printed on the valve cap. | 4,032 units | 2013-03-21 |
| 2004-02-10 | Not classified | Other | The Foley trays contain a 16 French catheter instead of an 18 French catheter as specified by the product insert/labeling. | 1100 units (110 cases) | 2004-07-09 |
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.