Dover
6 catalogue numbers from P4A, listed by Cardinal Health, United States, under Device, Urine Flow Rate Measuring, Non-Electrical, Disposable. 19 manufacturers in China are registered for this product code.
19manufacturers in China registered for this device type
6catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (10), Zhejiang (5), Shanghai (3). 5 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 |
| Conod Medical Co., Limited | Changshu | Jiangsu | Contract manufacturer | 48 |
| Conod Medical Shuyang Co., Ltd. | Shuyang | Jiangsu | Contract manufacturer | 22 |
| Anhui Careplus Medical Technology Co., Ltd. | Xuancheng | Anhui | Contract manufacturer | 6 |
| Jinhua Kangdeli Medical Appliances Co., Ltd. | Jinhua | Zhejiang | Contract manufacturer | 5 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Zhejiang Lidesen Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 100 |
| Anji Spenq Industrial Co., Ltd. | Huzhou | Zhejiang | Manufacturer | 85 |
| Ningbo Greetmed Medical Instruments Co., Ltd. | Ningbo | Zhejiang | Specification developer | 75 |
| Sterigenics Shanghai ETO Ltd. | Shanghai | Shanghai | Contract manufacturer | 65 |
| Suzhou Texnet | Suzhou | Jiangsu | Contract manufacturer | 47 |
Showing 12 of 19. All 19 manufacturers in China registered for Device, Urine Flow Rate Measuring, Non-Electrical, Disposable
Record
| Listed by | Cardinal Health, United States |
|---|---|
| FDA product code | FFG |
| Device type | Device, Urine Flow Rate Measuring, Non-Electrical, Disposable |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1800 |
| Establishment | Contract manufacturer, Reprocessor, Contract steriliser, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-09-24 |
| Record revised | 2026-05-27 (version 10) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 15 to 30 °C |
| Packaging | Case of 10, case of 300, pack_or_inner_pack of 30 |
| Sizes | Total volume 100 to 400 ml; catheter gauge 16 to 18 Fr |
| Distribution end date | 2025-12-31 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| P4A | Total Volume 400 ml | In distribution | |
| P4P16TS | Catheter Gauge 16 Fr | Withdrawn | |
| P4P16XTS | Catheter Gauge 16 Fr | Withdrawn | |
| 145500 | Total Volume 100 ml | 50 | Withdrawn |
| 145501 | Total Volume 100 ml | Withdrawn | |
| P4P18TS | Catheter Gauge 18 Fr | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Dover | Cardinal Health 200, LLC | 14 |
| Medline | Medline Industries, Inc. | 10 |
| AMSure® Urine Meter Drainage Bag | Amsino Medical Inc. | 2 |
| Bard® CritiCore® Collection Container | C.R. Bard, Inc. | 1 |
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.