Dover
100% Silicone Urine Meter Foley Tray with Coude Tip, 16 Fr Ch 5.3 mm 5 mL Catheter Pre connected to 2000 mL Drainage Bag with Luer Lock Sampling and Adhesive Catheter Securement
17manufacturers in China registered for this device type
85catalogue numbers in this listing
1recall
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 | Cardinal Health 200, LLC, United States |
|---|---|
| FDA product code | EZL |
| Device type | Catheter, Retention Type, Balloon |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5130 |
| Establishment | Contract manufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-05-02 |
| Record revised | 2025-12-31 (version 11) |
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 |
| Storage | Storage environment temperature -15 to 49 °C |
| Packaging | Carton of 10, case of 10, carton of 12, case of 6 |
| Sizes | Catheter gauge 12 to 26 Fr; total volume 5 to 2000 ml |
| Distribution end date | 2025-12-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1624C | In distribution | |
| 8888760524 | Total Volume 5 ml | In distribution |
| 8403 | In distribution | |
| 8887665209 | Catheter Gauge 20 Fr | In distribution |
| 8887665183 | Catheter Gauge 18 Fr | In distribution |
| 1618C | In distribution | |
| 8888763020 | In distribution | |
| 8888760308 | In distribution | |
| 8888760516 | Catheter Gauge 16 Fr | In distribution |
| 605189IC | In distribution | |
| 665183IC | Catheter Gauge 18 Fr | In distribution |
| 665209IC | Catheter Gauge 20 Fr | In distribution |
| 1616C | In distribution | |
| 8887630260 | Catheter Gauge 26 Fr | In distribution |
| 8888760512 | Catheter Gauge 12 Fr | In distribution |
| 6148ICLL | Total Volume 2000 ml | In distribution |
| 1424C | In distribution | |
| 1622C | In distribution | |
| 8888760518 | Catheter Gauge 18 Fr | In distribution |
| 605262IC | In distribution | |
| 20518ICC | In distribution | |
| P4P16CSD | Catheter Gauge 16 Fr | In distribution |
| 8404 | In distribution | |
| 1518C | In distribution | |
| 630260IC | In distribution | |
| 630187IC | In distribution | |
| 23018ICC | In distribution | |
| 1418C | In distribution | |
| 8888763022 | In distribution | |
| 665225IC | Catheter Gauge 22 Fr | In distribution |
| 20520ICC | In distribution | |
| 8888760522 | Catheter Gauge 22 Fr | In distribution |
| 8887665241 | Catheter Gauge 24 Fr | In distribution |
| 1520C | In distribution | |
| 665241IC | Total Volume 30 ml | In distribution |
| 6146ICLL | Total Volume 2000 ml | In distribution |
| 8888760526 | Catheter Gauge 26 Fr | In distribution |
| 8887665225 | Catheter Gauge 22 Fr | In distribution |
| 1524C | In distribution | |
| 605163IC | In distribution | |
| 8888760514 | Catheter Gauge 14 Fr | In distribution |
| 1512C | In distribution | |
| 1514C | In distribution | |
| 8887648221 | Catheter Gauge 22 Fr | In distribution |
| 1612C | In distribution | |
| 23020ICC | In distribution | |
| 1420C | In distribution | |
| 1620C | In distribution | |
| 8888760520 | Catheter Gauge 20 Fr | In distribution |
| 1422C | In distribution | |
| 8888760310 | In distribution | |
| 8888763024 | In distribution | |
| 1416C | In distribution | |
| 8888763018 | In distribution | |
| 1516C | In distribution | |
| 1522C | In distribution | |
| 1614C | In distribution | |
| 630229IC | Withdrawn | |
| 6146ICLL | Total Volume 2000 ml | Withdrawn |
| 605148IC | Withdrawn | |
| 605221IC | Withdrawn | |
| 665183IC | Catheter Gauge 18 Fr | Withdrawn |
| 605205IC | Withdrawn | |
| 6148ICLL | Total Volume 2000 ml | Withdrawn |
| 665225IC | Catheter Gauge 22 Fr | Withdrawn |
| 20522ICC | Withdrawn | |
| 630187IC | Withdrawn | |
| 665209IC | Catheter Gauge 20 Fr | Withdrawn |
| 6148ICLL | Catheter Gauge 18 Fr | Withdrawn |
| 23018ICC | Withdrawn | |
| 630260IC | Withdrawn | |
| 23020ICC | Withdrawn | |
| 20512ICC | Withdrawn | |
| 20516ICC | Withdrawn | |
| 20514ICC | Withdrawn | |
| 630245IC | Withdrawn | |
| 630203IC | Withdrawn | |
| 20518ICC | Withdrawn | |
| 20520ICC | Withdrawn | |
| 6146ICLL | Catheter Gauge 16 Fr | Withdrawn |
| 605247IC | Withdrawn | |
| 605262IC | Withdrawn | |
| 605189IC | Withdrawn | |
| 605163IC | Withdrawn | |
| 605122IC | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| All Silicone Foley Catheter | Well Lead Medical Co., Ltd. | 175 |
| 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 |
| AMSure® Silicone Coated Latex Foley Catheter | Amsino Medical Inc. | 28 |
Showing 12 of 135. All products under Catheter, Retention Type, Balloon
Recalls
1 of these is Class I. Class I is the FDA’s most serious grade: a reasonable probability of serious injury or death. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2023-12-04 | Class I | Nonconforming Material/Component | Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist. | 4620 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.