Dover
Silicone Elastomer Coated Latex Foley Catheter,Nylon Spiral Reinforced Catheter Wall, 30-50 mL, 2-Way
9manufacturers in China registered for this device type
152catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (3), Zhejiang (3), Guangdong (2). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Well Lead Medical Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 46 |
| Suzhou Jingle Polymer Medical Apparatus Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Guangdong Ecan Medical Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 14 |
| Clinisupplies (Nanjing) Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 13 |
| Integral Medical Products Co., Ltd. | Shaoxing | Zhejiang | Contract manufacturer | 7 |
| Hangzhou Jimushi Meditech Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 6 |
| Sterigenics Shanghai ETO Ltd. | Shanghai | Shanghai | Contract manufacturer | 65 |
| Steris Sterilization Technologies (Suzhou) Ltd | Suzhou | Jiangsu | Contract manufacturer | 44 |
| Integral Sterilization Technology (Shaoxing) Co., Ltd. | Shaoxing | Zhejiang | Contract manufacturer | 5 |
Record
| Listed by | Cardinal Health, United States |
|---|---|
| FDA product code | KOD |
| Device type | Catheter, Urological |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5130 |
| Establishment | Contract manufacturer, Reprocessor, Contract steriliser, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K833790 |
| Record published | 2016-09-24 |
| Record revised | 2026-06-12 (version 17) |
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 | Special storage condition: ; |
| Packaging | Pack_or_inner_pack of 10, case of 100, case of 60, pack_or_inner_pack of 12, case of 120, carton of 10 |
| Sizes | Catheter gauge 6 to 30 Fr; total volume 3 to 30 ml; length 16 in; length 40 to 43 mm; length 50 cm; width 35 mm |
| Distribution end date | 2026-07-01 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 1420 | Total Volume 30 ml | In distribution | |
| 3567 | Total Volume 5 ml | In distribution | |
| 8887664203 | Catheter Gauge 20 Fr | In distribution | |
| 40518L | Catheter Gauge 18 Fr | In distribution | |
| 1628 | Catheter Gauge 28 Fr | In distribution | |
| 8887688201 | Total Volume 5 ml | In distribution | |
| 1614 | Catheter Gauge 14 Fr | In distribution | |
| 8887689209 | Catheter Gauge 20 Fr | In distribution | |
| 8887648221 | Size Type – Total Volume, 30-50 ML; | In distribution | |
| 3575 | Total Volume 5 ml | In distribution | |
| 8887649245 | Size Type – Total Volume, 30-50 ML; | In distribution | |
| 400614 | Catheter Gauge 14 Fr | In distribution | |
| 402724 | Catheter Gauge 24 Fr | In distribution | |
| 8887630305 | Catheter Gauge 30 Fr | In distribution | |
| 3558 | In distribution | ||
| 3565 | Total Volume 5 ml | In distribution | |
| 1612 | Total Volume 5 ml | In distribution | |
| 1621 | Total Volume 5 ml | In distribution | |
| 3560 | Width 35 mm | In distribution | |
| 403718 | Catheter Gauge 18 Fr | In distribution | |
| 403712 | Catheter Gauge 12 Fr | In distribution | |
| 1619 | Catheter Gauge 18 Fr | In distribution | |
| 8887654104 | Total Volume 3 ml | In distribution | |
| 6108 | Catheter Gauge 18 Fr | In distribution | |
| 3618 | Total Volume 30 ml | In distribution | |
| 40522L | Catheter Gauge 22 Fr | In distribution | |
| 403724 | Total Volume 30 ml | In distribution | |
| 8887689167 | Catheter Gauge 14 Fr | In distribution | |
| 8887623125 | In distribution | ||
| 403730 | Catheter Gauge 30 Fr | In distribution | |
| 403720 | Catheter Gauge 20 Fr | In distribution | |
| 8887664182 | Total Volume 5 ml | In distribution | |
| 8887688185 | Catheter Gauge 18 Fr | In distribution | |
| 403714 | Catheter Gauge 14 Fr | In distribution | |
| 8887688169 | Total Volume 5 ml | In distribution | |
| 1622 | Total Volume 5 ml | In distribution | |
| 40516L | Total Volume 5 ml | In distribution | |
| 3601 | Catheter Gauge 16 Fr | In distribution | |
| 3631 | Total Volume 30 ml | In distribution | |
| 403726 | Catheter Gauge 26 Fr | In distribution | |
| 1631 | Total Volume 5 ml | In distribution | |
| 8887689241 | Total Volume,5-10,Milliliter; | In distribution | |
| 8887689225 | Total Volume 5 ml | In distribution | |
| 402730 | Total Volume 5 ml | In distribution | |
| 1616 | Total Volume 5 ml | In distribution | |
| 8887664287 | Catheter Gauge 28 Fr | In distribution | |
| 8887664266 | Total Volume 5 ml | In distribution | |
| 8887665161 | Catheter Gauge 16 Fr | In distribution | |
| 1426 | Catheter Gauge 26 Fr | In distribution | |
| 8887688227 | Total Volume 5 ml | In distribution | |
| 1424 | Catheter Gauge 24 Fr | In distribution | |
| 402716 | Total Volume 5 ml | In distribution | |
| 8887649229 | Sire Type – Total Volume, 30-50 ML; | In distribution | |
| 1419 | Catheter Gauge 18 Fr | In distribution | |
| 8887630284 | Catheter Gauge 28 Fr | In distribution | |
| 402720 | Total Volume 5 ml | In distribution | |
| 8887664224 | Total Volume 5 ml | In distribution | |
| 3607 | Total Volume 30 ml | In distribution | |
| 403722 | Total Volume 30 ml | In distribution | |
| 3577 | Catheter Gauge 30 Fr | In distribution | |
| 8887689266 | Catheter Gauge 26 Fr | In distribution | |
| 3573 | Catheter Gauge 26 Fr | In distribution | |
| 8887664245 | Total Volume 5 ml | In distribution | |
| 3619 | Total Volume 30 ml | In distribution | |
| 1416 | Catheter Gauge 16 Fr | In distribution | |
| 403728 | Catheter Gauge 28 Fr | In distribution | |
| 3614 | Catheter Gauge 22 Fr | In distribution | |
| 23026C | Total Volume 30 ml | In distribution | |
| 3570 | Catheter Gauge 24 Fr | In distribution | |
| 3563 | Total Volume 5 ml | In distribution | |
| 3623 | Catheter Gauge 28 Fr | In distribution | |
| 40520L | Total Volume 5 ml | In distribution | |
| 8887688268 | Length 50 cm | In distribution | |
| 8887688243 | Length 40 mm | In distribution | |
| 6006 | Catheter Gauge 6 Fr | In distribution | |
| 1422 | Catheter Gauge 22 Fr | In distribution | |
| 8887648247 | Size Type – Total Volume, 30-50 ML; | In distribution | |
| 403716 | Total Volume 30 ml | In distribution | |
| 8887654088 | Catheter Gauge 8 Fr | In distribution | |
| 8887689183 | Total Volume 30 ml | In distribution | |
| 23024C | Total Volume 30 ml | In distribution | |
| 1626 | Total Volume 5 ml | In distribution | |
| 402728 | Total Volume 5 ml | In distribution | |
| 1427 | Total Volume 30 ml | In distribution | |
| 8887665283 | Total Volume 30 ml | In distribution | |
| 1431 | Catheter Gauge 30 Fr | In distribution | |
| 402714 | Catheter Gauge 14 Fr | In distribution | |
| 1624 | Total Volume 5 ml | In distribution | |
| 402712 | Catheter Gauge 12 Fr | In distribution | |
| 20512C | Withdrawn | ||
| 23022C | Total Volume 30 ml | Withdrawn | |
| 2718 | Catheter Gauge 18 Fr | Withdrawn | |
| 8888492033 | Catheter Gauge 12 Fr | Withdrawn | |
| 8888492058 | Length 16 in | Withdrawn | |
| 20518C | Total Volume 5 ml | Withdrawn | |
| 8888492017 | Catheter Gauge 8 Fr | Withdrawn | |
| 5558492020 | 250 | Withdrawn | |
| 2821 | Total Volume 30 ml | Withdrawn | |
| 8887660263 | Catheter Gauge 26 Fr | Withdrawn | |
| 8887623125 | Total Volume 5 ml | Withdrawn | |
| 8887665262 | Total Volume 30 ml | Withdrawn | |
| 8887664161 | Total Volume 5 ml | Withdrawn | |
| 400610 | Catheter Gauge 10 Fr | Withdrawn | |
| 402718 | Catheter Gauge 18 Fr | Withdrawn | |
| 2720 | Total Volume 5 ml | Withdrawn | |
| 20524C | Catheter Gauge 24 Fr | Withdrawn | |
| 402722 | Total Volume 5 ml | Withdrawn | |
| 2824 | Catheter Gauge 24 Fr | Withdrawn | |
| 8887630163 | Total Volume 30 ml | Withdrawn | |
| 2822 | Total Volume 30 ml | Withdrawn | |
| 40524L | Catheter Gauge 24 Fr | Withdrawn | |
| 8888492122 | Catheter Gauge 22 Fr | Withdrawn | |
| 6947LF | Catheter Gauge 14 Fr | Withdrawn | |
| 8887660284 | Catheter Gauge 28 Fr | Withdrawn | |
| 402726 | Total Volume 5 ml | Withdrawn | |
| 8888492120 | Length 16 in | Withdrawn | |
| 20520C | Withdrawn | ||
| 1818 | Catheter Gauge 18 Fr | Withdrawn | |
| 8887624149 | Withdrawn | ||
| 2722 | Catheter Gauge 22 Fr | Withdrawn | |
| 400616 | Catheter Gauge 16 Fr | Withdrawn | |
| 23020C | Catheter Gauge 20 Fr | Withdrawn | |
| 20522C | Withdrawn | ||
| 2819 | Total Volume 30 ml | Withdrawn | |
| 8888492066 | Length 16 in | Withdrawn | |
| 1814 | Catheter Gauge 14 Fr | Withdrawn | |
| 50516T | Catheter Gauge 16 Fr | Withdrawn | |
| 20514C | Catheter Gauge 14 Fr | Withdrawn | |
| 8888492126 | Length 16 in | Withdrawn | |
| 5558492046 | Catheter Gauge 14 Fr | 250 | Withdrawn |
| 50514T | Total Volume 5 ml | Withdrawn | |
| 8888492025 | Length 16 in | Withdrawn | |
| 50518T | Catheter Gauge 18 Fr | Withdrawn | |
| 400608 | Catheter Gauge 8 Fr | Withdrawn | |
| 8887605282 | Catheter Gauge 28 Fr | Withdrawn | |
| 8888492041 | Length 16 in | Withdrawn | |
| 400618 | Catheter Gauge 18 Fr | Withdrawn | |
| 2826 | Total Volume 30 ml | Withdrawn | |
| 8888492128 | Length 16 in | Withdrawn | |
| 8888492124 | Length 16 in | Withdrawn | |
| 1817 | Catheter Gauge 16 Fr | Withdrawn | |
| 3611 | Catheter Gauge 20 Fr | Withdrawn | |
| 20516C | Total Volume 5 ml | Withdrawn | |
| 400612 | Catheter Gauge 12 Fr | Withdrawn | |
| 23018C | Total Volume 30 ml | Withdrawn | |
| 8887605303 | Total Volume 5 ml | Withdrawn | |
| 2723 | Total Volume 5 ml | Withdrawn | |
| 8887630142 | Total Volume 30 ml | Withdrawn | |
| 8887660221 | Catheter Gauge 22 Fr | Withdrawn | |
| 8887660305 | Catheter Gauge 30 Fr | Withdrawn | |
| 8887660242 | Catheter Gauge 24 Fr | Withdrawn | |
| 8888492130 | Catheter Gauge 30 Fr | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Rusch | Teleflex Medical LLC | 432 |
| Dover | Cardinal Health 200, LLC | 163 |
| MTG | HR Pharmaceuticals Inc. | 59 |
| Cook | Cook Incorporated | 43 |
| Bardex® Lubricath® Foley Catheter | C.R. Bard, Inc. | 30 |
| Magic3™ Intermittent Catheter | C.R. Bard, Inc. | 30 |
| Ureteral Catheter | Well Lead Medical Co., Ltd. | 26 |
| Bardex® Urethral Catheter Robinson Model | C.R. Bard, Inc. | 26 |
| Personal Catheter™ Intermittent Catheter | C.R. Bard, Inc. | 24 |
| DeRoyal | Deroyal Industries, Inc. | 23 |
| Bard® Robinson Catheter | C.R. Bard, Inc. | 22 |
| Flexi-Tip | Cook Incorporated | 20 |
Showing 12 of 150. All products under Catheter, Urological
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. | 924 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.