Bard Vertus Foley Catheter
Bard Vertus Foley Catheter 5cc Balloon with COMFORTGUARD Coating
17manufacturers in China registered for this device type
2catalogue numbers in this listing
10510(k) clearances naming this product code
9recalls on this code
Who Else Makes It
Concentrated in Jiangsu (5), Zhejiang (4), Guangdong (3). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dongguan BAO Kang Dian ZI KE JI Limited | Dongguan | Guangdong | Contract manufacturer | 24 |
| Primecare Medical (Suzhou) Co., Ltd. | Changshu | Jiangsu | Contract manufacturer | 20 |
| Haiyan Kangyuan Medical Instrument Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 17 |
| Primecare Medical (Huzhou) Co., Ltd. | Hu Zhou | Zhejiang | Contract manufacturer | 9 |
| Bioxin Medical Co., Ltd. | Weihai | Shandong | Contract manufacturer | 8 |
| Well Lead Medical (Hainan) Co., Ltd. | Haikou | Hainan | Contract manufacturer | 3 |
| Amsino Medical (Kunshan) Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 53 |
| Well Lead Medical Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 46 |
| Hangzhou Fushan Medical Appliance Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 44 |
| Changshu Rozer Sterilization Technology Co., Ltd. | Changshu | Jiangsu | Contract manufacturer | 43 |
| Hangzhou Primecare Medical Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 29 |
| Amsino Medical (Shanghai) Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 22 |
Showing 12 of 17. All 17 manufacturers in China registered for Catheter, Retention Type, Balloon
Record
| Listed by | C.R. Bard, Inc., United States |
|---|---|
| FDA product code | EZL |
| Device type | Catheter, Retention Type, Balloon |
| 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 | 2019-10-21 |
| 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 |
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 12 |
| Sizes | Catheter gauge 16 to 18 Fr |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 0165B16 | Catheter Gauge 16 Fr | In distribution |
| 0165B18 | Catheter Gauge 18 Fr | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| All Silicone Foley Catheter | Well Lead Medical Co., Ltd. | 175 |
| Dover | Cardinal Health 200, LLC | 85 |
| Dover | Cardinal Health | 82 |
| Rusch | Teleflex Medical LLC | 79 |
| Porges Coloplast | Coloplast A/S | 74 |
| Medline | Medline Industries, Inc. | 72 |
| McKesson | Mckesson Medical-Surgical Inc. | 63 |
| TruCath | HR Pharmaceuticals Inc. | 59 |
| Folysil | Coloplast A/S | 47 |
| Sunmed | SunMed Group Holdings, LLC | 35 |
| Universa | Cook Incorporated | 31 |
| AMSure ® Hydrophilic Latex Foley Catheters | Amsino Medical Inc. | 31 |
Showing 12 of 135. All products under Catheter, Retention Type, Balloon
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K180781 | 2018-09-19 |
| K150699 | 2015-07-28 |
| K070582 | 2007-12-07 |
| K070558 | 2007-12-07 |
| K070508 | 2007-03-09 |
| K040504 | 2004-05-14 |
| K002612 | 2002-09-03 |
| K003289 | 2001-01-05 |
| K002868 | 2000-12-08 |
| K951103 | 1995-04-28 |
Recalls
8 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. | 283883 trays/kits | |
| 2026-04-23 | Class II | Material/Component Contamination | Due to stain present on the surface of affected foley catheters. | 106,160 | |
| 2025-06-18 | Class II | Process design | Foley catheter may have an obstructed lumen, which may result in an inability to drain the bladder, of urine and may include pelvic or abdominal pain, flank pain, bladder dysfunction, obstructive uropathy, acute kidney injury and/or hydrone | 175,158 | |
| 2021-08-05 | Class II | Packaging change control | There is potential for packaging defects that may impact the sterile barrier. | 1440 units | |
| 2021-08-05 | Class II | Packaging change control | There is potential for packaging defects that may impact the sterile barrier. | 6440 units | |
| 2021-08-05 | Class II | Packaging change control | There is potential for packaging defects that may impact the sterile barrier. | 40 units | |
| 2021-08-05 | Class II | Packaging change control | There is potential for packaging defects that may impact the sterile barrier. | 4830 units | |
| 2016-07-11 | Class II | Device Design | During an FDA inspection it was found out that the Practical Foley Catheters to be potentially nonsterile. | 274 units | 2017-03-22 |
| 2016-07-11 | Class II | Device Design | During an FDA inspection it was found out that the Practical Foley Catheters to be potentially nonsterile. | 274 units | 2017-03-22 |
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.