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
11manufacturers in China registered for this device type
55catalogue numbers in this listing
1recall
Who Else Makes It
Concentrated in Jiangsu (6), Zhejiang (5). 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 |
| Shaoxing Jiancheng Medical Products Co., Ltd. | Shaoxing | Zhejiang | Contract manufacturer | 9 |
| Integral Medical Products Co., Ltd. | Shaoxing | Zhejiang | Contract manufacturer | 7 |
| Shaoxing Fuqing Health Products Co., Ltd. | Shaoxing | Zhejiang | Contract manufacturer | 3 |
| Changshu Rozer Sterilization Technology Co., Ltd. | Changshu | Jiangsu | Contract manufacturer | 43 |
| Joykey Industrial (Pinghu) Limited | Pinghu | Zhejiang | Contract manufacturer | 43 |
| Rozer Sterilization Technology Shuyang Company Limited | Shuyang | Jiangsu | Contract manufacturer | 33 |
| Nanjing Anjian Medical Device Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 22 |
| Suzhou Prosteri Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 20 |
| Integral Sterilization Technology (Shaoxing) Co., Ltd. | Shaoxing | Zhejiang | Contract manufacturer | 5 |
Record
| Listed by | Cardinal Health 200, LLC, United States |
|---|---|
| FDA product code | FCM |
| Device type | Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5130 |
| Establishment | Contract manufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Record published | 2026-01-16 |
| Record revised | 2025-12-31 (version 13) |
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 30 °C |
| Packaging | Case of 20, case of 10 |
| Sizes | Catheter gauge 14 to 18 Fr; total volume 5 to 2000 ml |
| Distribution end date | 2026-07-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 3141 | Catheter Gauge 14 Fr | In distribution |
| 5029 | In distribution | |
| 76020 | In distribution | |
| 6175 | Total Volume 2000 ml | In distribution |
| 3044 | Catheter Gauge 18 Fr | In distribution |
| 75005 | Catheter Gauge 14 Fr | In distribution |
| 3408 | Catheter Gauge 16 Fr | In distribution |
| 75035 | Catheter Gauge 14 Fr | In distribution |
| 2480 | Total Volume 1000 ml | In distribution |
| 5027 | In distribution | |
| 3410 | Catheter Gauge 14 Fr | In distribution |
| 76010 | In distribution | |
| 76012 | In distribution | |
| 2006 | Total Volume 400 ml | In distribution |
| 3215 | Catheter Gauge 16 Fr | In distribution |
| 8887600776 | Total Volume 5 ml | In distribution |
| 8887600784 | Catheter Gauge 18 Fr | In distribution |
| 3305 | In distribution | |
| 76030 | In distribution | |
| 75030 | Catheter Gauge 14 Fr | In distribution |
| 75010 | In distribution | |
| 75000 | Catheter Gauge 14 Fr | In distribution |
| 3217 | Catheter Gauge 14 Fr | In distribution |
| 7100 | In distribution | |
| 3450 | Catheter Gauge 14 Fr | In distribution |
| 76000 | In distribution | |
| 8887600073 | Catheter Gauge 14 Fr | In distribution |
| 2101 | Catheter Gauge 16 Fr | In distribution |
| 3408 | Catheter Gauge 16 Fr | Withdrawn |
| 75005 | Catheter Gauge 14 Fr | Withdrawn |
| 8887600073 | Catheter Gauge 14 Fr | Withdrawn |
| 7100 | Withdrawn | |
| 8887600784 | Catheter Gauge 18 Fr | Withdrawn |
| 6175 | Total Volume 2000 ml | Withdrawn |
| 3305 | Withdrawn | |
| 3141 | Catheter Gauge 14 Fr | Withdrawn |
| 8887600776 | Catheter Gauge 16 Fr | Withdrawn |
| 5027 | Withdrawn | |
| 8949 | Catheter Gauge 16 Fr | Withdrawn |
| 8887600776 | Catheter Gauge 16 Fr | Withdrawn |
| 3044 | Total Volume 5 ml | Withdrawn |
| 3217 | Catheter Gauge 14 Fr | Withdrawn |
| 2101 | Total Volume 5 ml | Withdrawn |
| 8949 | Catheter Gauge 16 Fr | Withdrawn |
| 3450 | Catheter Gauge 14 Fr | Withdrawn |
| 8887600073 | Catheter Gauge 14 Fr | Withdrawn |
| 2006 | Total Volume 400 ml | Withdrawn |
| 5027 | Withdrawn | |
| 2006 | Catheter Gauge 16 Fr | Withdrawn |
| 3410 | Catheter Gauge 14 Fr | Withdrawn |
| 76010 | Withdrawn | |
| 5029 | Withdrawn | |
| 2006 | Total Volume 400 ml | Withdrawn |
| 8887600784 | Catheter Gauge 18 Fr | Withdrawn |
| 75010 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Dover | Cardinal Health | 72 |
| Gentlecath | Convatec, Purchasing Department | 28 |
| AMSure® Foley Catheter Tray | Amsino Medical Inc. | 26 |
| Medline Industries, Inc. | Medline Industries, Inc. | 20 |
| Self-Cath Closed System | Coloplast A/S | 20 |
| Cure Catheter® Closed System | Convatec, Purchasing Department | 17 |
| Nurse Assist | Nurse Assist, LLC | 17 |
| Bard® Touchless® Plus Unisex Pre-Lubricated Vinyl Urethral Catheter | C.R. Bard, Inc. | 13 |
| Apogee Plus | Hollister Incorporated | 12 |
| Advance Plus | Hollister Incorporated | 9 |
| AMSure ® Foley Catheters Tray | Amsino Medical Inc. | 9 |
| Medline | Medline Industries, Inc. | 8 |
Showing 12 of 45. All products under Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)
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 |
|---|---|---|---|---|---|
| Cardinal Health | UDI-DI | 2022-11-01 | Class II | Equipment maintenance | Occlusion (blockage) of the bubble inlet port of the urinary drainage bag which may prevent urine draining into the bag. If the bladder is not emptied within a clinically appropriate time, this may increase the risk of urinary retention |
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. | 17640 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.