Dover
100% Silicone Urine Meter Foley Tray with Coude Tip, 16 FrCh 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
82catalogue numbers in this listing
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, United States |
|---|---|
| FDA product code | EZL |
| Device type | Catheter, Retention Type, Balloon |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5130 |
| Establishment | Contract manufacturer, Reprocessor, Contract steriliser, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| Record published | 2016-09-24 |
| Record revised | 2023-12-29 (version 16) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Keep dry;AVOID DIRECT SUNLIGHT |
| Packaging | Pack_or_inner_pack of 10, case of 100, case of 120, pack_or_inner_pack of 12, case of 10, inner_pack of 12 |
| Sizes | Total volume 5 to 400 ml; catheter gauge 12 to 26 Fr |
| Distribution end date | 2025-12-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1524C | Catheter Gauge 24 Fr | In distribution |
| 1424C | Total Volume 30 ml | In distribution |
| 1520C | Catheter Gauge 20 Fr | In distribution |
| 1624C | Total Volume 5 ml | In distribution |
| 8404 | Catheter Gauge 16 Fr | In distribution |
| 1618C | Catheter Gauge 18 Fr | In distribution |
| 1422C | Catheter Gauge 22 Fr | In distribution |
| 7008IC | Total Volume,400 and 5 Catheter and 2000 Drainage Bag,Milliliter; | In distribution |
| 1518C | Total Volume 5 ml | In distribution |
| 1416C | Catheter Gauge 16 Fr | In distribution |
| 1612C | Total Volume 5 ml | In distribution |
| 1620C | Total Volume 5 ml | In distribution |
| 1514C | Catheter Gauge 14 Fr | In distribution |
| 1522C | Catheter Gauge 22 Fr | In distribution |
| 1616C | Catheter Gauge 16 Fr | In distribution |
| 1516C | Catheter Gauge 16 Fr | In distribution |
| 1418C | Catheter Gauge 18 Fr | In distribution |
| 1420C | Catheter Gauge 20 Fr | In distribution |
| 1512C | Catheter Gauge 12 Fr | In distribution |
| 1614C | Catheter Gauge 14 Fr | In distribution |
| 1622C | Catheter Gauge 22 Fr | In distribution |
| 23018ICC | Total Volume 30 ml | Withdrawn |
| 665225IC | Total Volume 30 ml | Withdrawn |
| 605163IC | Total Volume 5 ml | Withdrawn |
| P4P18XTS | Catheter Gauge 18 Fr | Withdrawn |
| 23020ICC | Catheter Gauge 20 Fr | Withdrawn |
| 665225IC | Catheter Gauge 22 Fr | Withdrawn |
| 630245IC | Total Volume 30 ml | Withdrawn |
| 630229IC | Catheter Gauge 22 Fr | Withdrawn |
| 605221IC | Total Volume 5 ml | Withdrawn |
| 20512ICC | Catheter Gauge 12 Fr | Withdrawn |
| 630187IC | Total Volume 30 ml | Withdrawn |
| P4P16CSD | Withdrawn | |
| 665241IC | Catheter Gauge 24 Fr | Withdrawn |
| 605189IC | Total Volume 5 ml | Withdrawn |
| 665209IC | Total Volume 30 ml | Withdrawn |
| 8887630260 | Total Volume 30 ml | Withdrawn |
| 605163IC | Total Volume 5 ml | Withdrawn |
| 605189IC | Total Volume 5 ml | Withdrawn |
| 630203IC | Total Volume 30 ml | Withdrawn |
| 605262IC | Catheter Gauge 26 Fr | Withdrawn |
| 6146LL | Catheter Gauge 16 Fr | Withdrawn |
| 605148IC | Total Volume 5 ml | Withdrawn |
| 665183IC | Catheter Gauge 18 Fr | Withdrawn |
| 20518ICC | Catheter Gauge 18 Fr | Withdrawn |
| 50518ICT | Total Volume 5 ml | Withdrawn |
| 630229IC | Total Volume 30 ml | Withdrawn |
| 630260IC | Total Volume 30 ml | Withdrawn |
| 630245IC | Total Volume 30 ml | Withdrawn |
| 8887665183 | Total Volume 30 ml | Withdrawn |
| 7006ICLL | Total Volume 400 ml | Withdrawn |
| 605221IC | Total Volume 5 ml | Withdrawn |
| 8887605189 | Total Volume,5,Milliliter; | Withdrawn |
| 8887665209 | Catheter Gauge 20 Fr | Withdrawn |
| 605122IC | Catheter Gauge 12 Fr | Withdrawn |
| 20516ICC | Catheter Gauge 16 Fr | Withdrawn |
| 8887605205 | Catheter Gauge 18 Fr | Withdrawn |
| 605148IC | Total Volume 5 ml | Withdrawn |
| 605247IC | Total Volume 5 ml | Withdrawn |
| 8887665241 | Catheter Gauge 24 Fr | Withdrawn |
| 630203IC | Total Volume 30 ml | Withdrawn |
| 605247IC | Total Volume 5 ml | Withdrawn |
| 665183IC | Total Volume 30 ml | Withdrawn |
| 605205IC | Total Volume 5 ml | Withdrawn |
| 20520ICC | Catheter Gauge 20 Fr | Withdrawn |
| 665241IC | Total Volume 30 ml | Withdrawn |
| 8887630229 | Catheter Gauge 22 Fr | Withdrawn |
| 630260IC | Total Volume 30 ml | Withdrawn |
| 7006IC | Total Volume 400 ml | Withdrawn |
| 6166LL | Withdrawn | |
| 8887630187 | Catheter Gauge 18 Fr | Withdrawn |
| 50516ICT | Withdrawn | |
| 7008LL | Total Volume 400 ml | Withdrawn |
| 605262IC | Total Volume 5 ml | Withdrawn |
| 7006LL | Catheter Gauge 16 Fr | Withdrawn |
| 8887665225 | Catheter Gauge 22 Fr | Withdrawn |
| 20522ICC | Catheter Gauge 22 Fr | Withdrawn |
| 665209IC | Total Volume 30 ml | Withdrawn |
| 605122IC | Total Volume 5 ml | Withdrawn |
| 630187IC | Total Volume 30 ml | Withdrawn |
| 20514ICC | Total Volume 5 ml | Withdrawn |
| 605205IC | Catheter Gauge 20 Fr | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| All Silicone Foley Catheter | Well Lead Medical Co., Ltd. | 175 |
| Dover | Cardinal Health 200, LLC | 85 |
| 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 Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Cardinal Health 200, LLC | UDI-DI | 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.