Dover
Hydrogel Coated Latex 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
72catalogue numbers in this listing
6recalls on this code
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, 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, Reprocessor, Contract steriliser, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-09-24 |
| Record revised | 2024-12-31 (version 14) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| 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 | Case of 20, pack_or_inner_pack of 10, case of 60, case of 10, case of 6, pack_of_inner_pack of 10 |
| Sizes | Catheter gauge 8 to 2000 Fr; total volume 3 to 2000 ml; length 48 cm; length 35 mm |
| Distribution end date | 2025-12-31 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 8887603085 | Catheter Gauge 8 Fr | In distribution | |
| 8887630245 | Total Volume 30 ml | In distribution | |
| 8887603085 | Catheter Gauge 8 Fr | In distribution | |
| 8887630245 | Total Volume 30 ml | In distribution | |
| 8887605148 | Catheter Gauge 14 Fr | In distribution | |
| 8887605163 | Length 35 mm | In distribution | |
| 8887630203 | Total Volume 30 ml | In distribution | |
| 8887630203 | Catheter Gauge 20 Fr | 10 | In distribution |
| 8887630203 | Total Volume 30 ml | In distribution | |
| 8887605148 | Total Volume 5 ml | In distribution | |
| 8887605163 | Catheter Gauge 16 Fr | In distribution | |
| 8887603101 | Total Volume,3,Milliliter; | Withdrawn | |
| 8887606187 | Total Volume 5 ml | Withdrawn | |
| 6255 | Catheter Gauge 18 Fr | Withdrawn | |
| 8887605262 | Total Volume,5,Milliliter; | Withdrawn | |
| 8887606146 | Total Volume 5 ml | Withdrawn | |
| 3143 | Catheter Gauge 14 Fr | Withdrawn | |
| 8887630245 | Total Volume,30,Milliliter; | Withdrawn | |
| 8887600776 | Catheter Gauge 16 Fr | Withdrawn | |
| 3450LF | Total Volume 1000 ml | Withdrawn | |
| 8887605189 | Total Volume,5-10,Milliliter; | Withdrawn | |
| 8887605122 | Catheter Gauge 12 Fr | Withdrawn | |
| 2014 | Total Volume 2000 ml | Withdrawn | |
| 8887630187 | Catheter Gauge 18 Fr | Withdrawn | |
| 8887606161 | Catheter Gauge 16 Fr | Withdrawn | |
| 2008 | Catheter Gauge 18 Fr | Withdrawn | |
| 407428 | Catheter Gauge 18 Fr | Withdrawn | |
| 2020 | Total Volume 2000 ml | Withdrawn | |
| 76020 | Withdrawn | ||
| 3044 | Total Volume 5 ml | Withdrawn | |
| 8887605247 | Total Volume 5 ml | Withdrawn | |
| 8887601220 | Total Volume 10 ml | Withdrawn | |
| 76000 | Withdrawn | ||
| 8887605221 | Catheter Gauge 10 Fr | Withdrawn | |
| 8887603101 | Total Volume,3-5,Milliliter; | Withdrawn | |
| 3217 | Catheter Gauge 14 Fr | Withdrawn | |
| 3420 | Catheter Gauge 14 Fr | Withdrawn | |
| 2018 | Catheter Gauge 18 Fr | Withdrawn | |
| 2016 | Catheter Gauge 16 Fr | Withdrawn | |
| 75035 | Catheter Gauge 14 Fr | Withdrawn | |
| 8887630229 | Catheter Gauge 22 Fr | Withdrawn | |
| 8887605262 | Total Volume,5-10,Milliliter; | Withdrawn | |
| 406622 | Catheter Gauge 14 Fr | Withdrawn | |
| 5029 | Total Volume 10 ml | Withdrawn | |
| 8887605247 | Catheter Gauge 8 Fr | Withdrawn | |
| 76030 | Withdrawn | ||
| 2480 | Catheter Gauge 14 Fr | Withdrawn | |
| 75039 | Catheter Gauge 14 Fr | Withdrawn | |
| 75030 | Catheter Gauge 14 Fr | Withdrawn | |
| 6256 | Total Volume 2000 ml | Withdrawn | |
| 8887605205 | Withdrawn | ||
| 6175 | Total Volume 2000 ml | Withdrawn | |
| 8887600784 | Total Volume 5 ml | Withdrawn | |
| 407716 | Total Volume 5 ml | Withdrawn | |
| 407020 | Total Volume 2000 ml | Withdrawn | |
| 2004 | Total Volume 14 ml | Withdrawn | |
| 8887606203 | Catheter Gauge 20 Fr | Withdrawn | |
| 8887605122 | Catheter Gauge 12 Fr | Withdrawn | |
| 3450 | Total Volume 1000 ml | Withdrawn | |
| 75000 | Catheter Gauge 14 Fr | Withdrawn | |
| 407718 | Catheter Gauge 18 Fr | Withdrawn | |
| 8887600057 | Catheter Gauge 14 Fr | Withdrawn | |
| 3215 | Catheter Gauge 16 Fr | Withdrawn | |
| 407426 | Catheter Gauge 16 Fr | Withdrawn | |
| 3305 | Withdrawn | ||
| 75020 | Withdrawn | ||
| 2101 | Total Volume 16 ml | Withdrawn | |
| 8887605221 | Catheter Gauge 10 Fr | Withdrawn | |
| 3410 | Catheter Gauge 14 Fr | Withdrawn | |
| 76012 | Withdrawn | ||
| 3141 | Catheter Gauge 14 Fr | Withdrawn | |
| 3307 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Dover | Cardinal Health 200, LLC | 55 |
| 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
6 recalls name this product by its own identifiers, 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. | 17640 units |
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| 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 II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason |
|---|---|---|---|
| 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 |
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.