Dover
Paediatric Silicone Coated Latex Foley Catheter;3 mL, 2-Way
11manufacturers in China registered for this device type
23catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (6), Jiangsu (4), Guangdong (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Suzhou Jingle Polymer Medical Apparatus Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Integral Medical Products Co., Ltd. | Shaoxing | Zhejiang | Contract manufacturer | 7 |
| Xianju Bever Medical Devices Co., Ltd. | Taizhou | Zhejiang | Contract manufacturer | 3 |
| Well Lead Medical Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 46 |
| Steris Sterilization Technologies (Suzhou) Ltd | Suzhou | Jiangsu | Contract manufacturer | 44 |
| Nanjing Anjian Medical Device Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 22 |
| Suzhou Prosteri Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 20 |
| Hangzhou Jimushi Meditech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 6 |
| Integral Sterilization Technology (Shaoxing) Co., Ltd. | Shaoxing | Zhejiang | Contract manufacturer | 5 |
| Hangzhou Bever Medical Devices Co., Ltd. | Hangzhou | Zhejiang | Specification developer | 3 |
| Xianju JF Medister Co., Ltd. | Taizhou | Zhejiang | Contract manufacturer | 2 |
Record
| Listed by | Cardinal Health, United States |
|---|---|
| FDA product code | GBM |
| Device type | Catheter, Urethral |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5130 |
| Establishment | Contract manufacturer, Reprocessor, Contract steriliser, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-09-24 |
| Record revised | 2025-12-31 (version 15) |
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 | Special storage condition: Keep dry;AVOID DIRECT SUNLIGHT |
| Packaging | Pack_or_inner_pack of 12, case of 120, case of 100, case of 10, pallet of 1500, case of 50 |
| Sizes | Catheter gauge 8 to 24 Fr |
| Distribution end date | 2025-12-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 8420 | Catheter Gauge 20 Fr | In distribution |
| 8410 | Catheter Gauge 10 Fr | In distribution |
| 2540 | Catheter Gauge 14 Fr | In distribution |
| 8412 | Catheter Gauge 12 Fr | In distribution |
| 11086 | Catheter Gauge 8 Fr | In distribution |
| 8416 | Catheter Gauge 16 Fr | In distribution |
| 8418 | Catheter Gauge 18 Fr | In distribution |
| 8403 | Catheter Gauge 14 Fr | In distribution |
| 8414 | Catheter Gauge 14 Fr | In distribution |
| 8424 | Catheter Gauge 24 Fr | In distribution |
| 8422 | Catheter Gauge 22 Fr | In distribution |
| 8408 | Catheter Gauge 8 Fr | In distribution |
| 7946 | Catheter Gauge 16 Fr | Withdrawn |
| 8887660168 | Catheter Gauge 16 Fr | Withdrawn |
| 8887660101 | Catheter Gauge 10 Fr | Withdrawn |
| 3170 | Catheter Gauge 14 Fr | Withdrawn |
| 8887660218 | Catheter Gauge 20 Fr | Withdrawn |
| 7948 | Catheter Gauge 18 Fr | Withdrawn |
| 8887660184 | Catheter Gauge 18 Fr | Withdrawn |
| 26203 | Catheter Gauge 20 Fr | Withdrawn |
| 8887660127 | Catheter Gauge 12 Fr | Withdrawn |
| 8887660143 | Catheter Gauge 14 Fr | Withdrawn |
| 8887660085 | Catheter Gauge 8 Fr | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| BeneCath® | Hangzhou Jimushi Meditech Co., Ltd. | 57 |
| SpeediCath Standard | Coloplast A/S | 47 |
| TruCath | HR Pharmaceuticals Inc. | 46 |
| VaPro | Hollister Incorporated | 31 |
| Actreen® | B. Braun Medical Inc. | 28 |
| McKesson | Mckesson Medical-Surgical Inc. | 25 |
| BD Intermittent | Hangzhou Bever Medical Devices Co., Ltd. | 24 |
| Gentlecath AIR | Convatec, Purchasing Department | 24 |
| VaPro Pocket | Hollister Incorporated | 23 |
| Apogee | Hollister Incorporated | 23 |
| Dover | Cardinal Health 200, LLC | 22 |
| Teleflex | Teleflex Medical LLC | 22 |
Showing 12 of 76. All products under Catheter, Urethral
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. | 36300 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.