Dover
Dover 100% Silicone Urine Meter Foley Tray 16 Fr/Ch (5.3 mm) • 5 mL Catheter Pre-connected to 2000 mL Drainage Bag with Needle Sampling
51manufacturers in China registered for this device type
53catalogue numbers in this listing
1recall
Who Else Makes It
Concentrated in Jiangsu (25), Zhejiang (9), Shanghai (5). 9 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 |
| Suzhou Jingle Polymer Medical Apparatus Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Sino Protection (Hefei) Medical Products Co., Ltd. | Hefei | Anhui | Contract manufacturer | 18 |
| Hitec Medical Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 17 |
| Forefront Medical Technology (Jiangsu) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 14 |
| Heyuan Hong DE Medical Products Co., Ltd. | Heyuan | Guangdong | Contract manufacturer | 13 |
| Meifu Medical Technology Suzhou Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 13 |
| Primecare Medical (Huzhou) Co., Ltd. | Hu Zhou | Zhejiang | Contract manufacturer | 9 |
| Anhui Careplus Medical Technology Co., Ltd. | Xuancheng | Anhui | Contract manufacturer | 6 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Huzhou Junda Industry Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 129 |
Showing 12 of 51. All 51 manufacturers in China registered for Collector, Urine, (And Accessories) For Indwelling Catheter
Record
| Listed by | Cardinal Health 200, LLC, United States |
|---|---|
| FDA product code | KNX |
| Device type | Collector, Urine, (And Accessories) For Indwelling Catheter |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5250 |
| Establishment | Contract manufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-09-24 |
| Record revised | 2026-02-24 (version 11) |
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 | Storage environment temperature 0 to 32 °C |
| Packaging | Case of 10, case of 20, case of 15, case of 24 |
| Sizes | Total volume 200 to 4000 ml; catheter gauge 14 to 18 Fr; length 18 in |
| Distribution end date | 2026-07-31 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 3057 | Total Volume 2000 ml | In distribution | |
| 8949 | Catheter Gauge 16 Fr | In distribution | |
| 8948 | Total Volume 2000 ml | In distribution | |
| 6206 | Total Volume 2000 ml | In distribution | |
| 7000 | Total Volume 400 ml | In distribution | |
| 8122 | Total Volume 200 ml | In distribution | |
| 6308 | Total Volume 2000 ml | In distribution | |
| 6208 | Total Volume 2000 ml | In distribution | |
| 8946 | Catheter Gauge 16 Fr | In distribution | |
| 7000LL | Total Volume 400 ml | In distribution | |
| 8944 | Catheter Gauge 14 Fr | In distribution | |
| 6261 | Total Volume 4000 ml | In distribution | |
| 6251 | Total Volume 1500 ml | In distribution | |
| 8884731900 | Length 18 in | 12 | In distribution |
| 8206 | Total Volume 2000 ml | In distribution | |
| 30510 | Total Volume 2000 ml | In distribution | |
| 3515 | Total Volume 2000 ml | In distribution | |
| 3512 | Total Volume 2000 ml | In distribution | |
| 8950 | Catheter Gauge 18 Fr | In distribution | |
| 6144ICLL | Catheter Gauge 14 Fr | In distribution | |
| 6308LL | In distribution | ||
| 7000LL | Total Volume 400 ml | Withdrawn | |
| 8206 | Total Volume 2000 ml | Withdrawn | |
| 6208 | Total Volume 2000 ml | Withdrawn | |
| PP16ULD | Catheter Gauge 16 Fr | Withdrawn | |
| 8122 | Catheter Gauge 16 Fr | Withdrawn | |
| 6144ICLL | Catheter Gauge 14 Fr | Withdrawn | |
| 8122 | Total Volume 200 ml | Withdrawn | |
| 6308 | Total Volume 2000 ml | Withdrawn | |
| PP14XSD | Catheter Gauge 14 Fr | Withdrawn | |
| 3515 | Total Volume 2000 ml | Withdrawn | |
| PP18ULD | Catheter Gauge 18 Fr | Withdrawn | |
| 8944 | Catheter Gauge 14 Fr | Withdrawn | |
| PP14ULD | Catheter Gauge 14 Fr | Withdrawn | |
| 3515 | Total Volume 2000 ml | Withdrawn | |
| PP16XSD | Catheter Gauge 16 Fr | Withdrawn | |
| 8946 | Catheter Gauge 16 Fr | Withdrawn | |
| PP16CSD | Catheter Gauge 16 Fr | Withdrawn | |
| 8946 | Catheter Gauge 16 Fr | Withdrawn | |
| 8950 | Catheter Gauge 18 Fr | Withdrawn | |
| 8122 | Catheter Gauge 16 Fr | Withdrawn | |
| 8948 | Catheter Gauge 18 Fr | Withdrawn | |
| PP18SD | Catheter Gauge 18 Fr | Withdrawn | |
| 3512 | Total Volume 2000 ml | Withdrawn | |
| PP18XSD | Catheter Gauge 18 Fr | Withdrawn | |
| 8950 | Catheter Gauge 18 Fr | Withdrawn | |
| 6261 | Total Volume 4000 ml | Withdrawn | |
| PP16SD | Catheter Gauge 16 Fr | Withdrawn | |
| PP14SD | Catheter Gauge 14 Fr | Withdrawn | |
| PP18CSD | Catheter Gauge 18 Fr | Withdrawn | |
| 6144ICLL | Catheter Gauge 14 Fr | Withdrawn | |
| 8948 | Catheter Gauge 18 Fr | Withdrawn | |
| 8950 | Catheter Gauge 18 Fr | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Dover | Cardinal Health | 71 |
| Urine Bag | Well Lead Medical Co., Ltd. | 64 |
| Medline | Medline Industries, Inc. | 19 |
| Rusch | Teleflex Medical LLC | 10 |
| Bard® Urine Meter with Bag | C.R. Bard, Inc. | 10 |
| Bard® Add-A-Foley Tray | C.R. Bard, Inc. | 10 |
| AMSure® Urinary Drainage Bag | Amsino Medical Inc. | 8 |
| Bard® Urinary Drainage Bag with Anti-Reflux Chamber | C.R. Bard, Inc. | 6 |
| Bard® Urinary Drainage Bag | C.R. Bard, Inc. | 6 |
| Uro-Safe® Disposable Vinyl Leg Bag 18 oz. (550 mL.) | Urocare Products, Inc. | 6 |
| Medline Industries, Inc. | Medline Industries, Inc. | 5 |
| SureStep™ Foley Tray System Complete Care® Add-A-Foley Catheter | C.R. Bard, Inc. | 5 |
Showing 12 of 113. All products under Collector, Urine, (And Accessories) For Indwelling Catheter
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. | 435060 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.