Bardia Leg Bag
Bardia Leg Bag, Medium (19oz)
51manufacturers in China registered for this device type
3catalogue numbers in this listing
3510(k) clearances naming this product code
6recalls on this code
Who Else Makes It
Concentrated in Jiangsu (25), Zhejiang (9), Shanghai (5). 9 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 |
| Suzhou Jingle Polymer Medical Apparatus Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Sino Protection (Hefei) Medical Products Co., Ltd. | Hefei | Anhui | Contract manufacturer | 18 |
| Hitec Medical Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 17 |
| Forefront Medical Technology (Jiangsu) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 14 |
| Heyuan Hong DE Medical Products Co., Ltd. | Heyuan | Guangdong | Contract manufacturer | 13 |
| Meifu Medical Technology Suzhou Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 13 |
| Primecare Medical (Huzhou) Co., Ltd. | Hu Zhou | Zhejiang | Contract manufacturer | 9 |
| Anhui Careplus Medical Technology Co., Ltd. | Xuancheng | Anhui | Contract manufacturer | 6 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Huzhou Junda Industry Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 129 |
Showing 12 of 51. All 51 manufacturers in China registered for Collector, Urine, (And Accessories) For Indwelling Catheter
Record
| Listed by | C.R. Bard, Inc., United States |
|---|---|
| FDA product code | KNX |
| Device type | Collector, Urine, (And Accessories) For Indwelling Catheter |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5250 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2020-09-22 |
| Record revised | 2021-04-07 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
| Packaging | Box of 12, case of 4 |
| Sizes | Total volume 9 to 32 Fluid Ounce |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 150106 | Total Volume 9 Fluid Ounce | In distribution |
| 150108 | Total Volume 32 Fluid Ounce | In distribution |
| 150107 | Total Volume 19 Fluid Ounce | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Dover | Cardinal Health | 71 |
| Urine Bag | Well Lead Medical Co., Ltd. | 64 |
| Dover | Cardinal Health 200, LLC | 53 |
| Medline | Medline Industries, Inc. | 19 |
| Rusch | Teleflex Medical LLC | 10 |
| Bard® Urine Meter with Bag | C.R. Bard, Inc. | 10 |
| Bard® Add-A-Foley Tray | C.R. Bard, Inc. | 10 |
| AMSure® Urinary Drainage Bag | Amsino Medical Inc. | 8 |
| Bard® Urinary Drainage Bag with Anti-Reflux Chamber | C.R. Bard, Inc. | 6 |
| Bard® Urinary Drainage Bag | C.R. Bard, Inc. | 6 |
| Uro-Safe® Disposable Vinyl Leg Bag 18 oz. (550 mL.) | Urocare Products, Inc. | 6 |
| Medline Industries, Inc. | Medline Industries, Inc. | 5 |
Showing 12 of 113. All products under Collector, Urine, (And Accessories) For Indwelling Catheter
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K940206 | 1994-09-16 |
| K844810 | 1985-07-24 |
| K802433 | 1980-10-31 |
Recalls
3 of these are Class II. Class II means a temporary or reversible health consequence. Class III is unlikely to cause harm at all → typically a labelling or documentation fault. 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. | 33850 units/kits | |
| 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. | 364 | |
| 2017-06-02 | Class II | Process control | Customer complaint of a cut in the side of the leg bag, indicating a potential breach of the product’s sterile barrier. | 2,350 units | 2021-07-26 |
| 2016-07-11 | Class II | Labeling mix-ups | The product contained a latex catheter instead of a silicone catheter. | 2690 units | 2021-10-05 |
| 2016-06-29 | Class III | Labeling mix-ups | Labeling problem | 530 units | 2017-12-05 |
| 2015-01-30 | Class II | Unknown/Undetermined by firm | Potential breach of the sterile barrier packaging. | 9,620 units | 2016-08-01 |
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.