Dover
100% Silicone Silver-Hydrogel Coated Foley Catheter, Coude TIP, 22 FR (7.3 MM), 5 CC, 2-WAY
9manufacturers in China registered for this device type
163catalogue numbers in this listing
1recall
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 200, LLC, United States |
|---|---|
| FDA product code | KOD |
| Device type | Catheter, Urological |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5130 |
| Establishment | Contract manufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Record published | 2024-02-29 |
| Record revised | 2026-02-24 (version 12) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature -15 to 49 °C |
| Packaging | Carton of 10, case of 10, case of 6, carton of 12, case of 100, case of 60 |
| Sizes | Catheter gauge 8 to 26 Fr; length 6.5 to 16 in; total volume 5 to 30 ml |
| Distribution end date | 2025-12-31 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 23026C | Catheter Gauge 26 Fr | In distribution | |
| 40522L | In distribution | ||
| 2821 | In distribution | ||
| 605221IC | In distribution | ||
| 1420 | In distribution | ||
| 8887605282 | In distribution | ||
| 2722 | In distribution | ||
| 3619 | In distribution | ||
| 20522ICC | In distribution | ||
| 2720 | In distribution | ||
| 3618 | In distribution | ||
| 1621 | In distribution | ||
| 8887664161 | In distribution | ||
| 3563 | In distribution | ||
| 8887688185 | In distribution | ||
| 50514T | Catheter Gauge 14 Fr | In distribution | |
| 3575 | In distribution | ||
| 8887630142 | In distribution | ||
| 20512CW | Catheter Gauge 12 Fr | In distribution | |
| 403724 | In distribution | ||
| 8887630163 | In distribution | ||
| 1424 | In distribution | ||
| 8888492126 | In distribution | ||
| 8887649245 | In distribution | ||
| 400612 | Catheter Gauge 12 Fr | In distribution | |
| 400610 | Catheter Gauge 10 Fr | In distribution | |
| 1427 | In distribution | ||
| 402728 | In distribution | ||
| 2819 | In distribution | ||
| 1422 | In distribution | ||
| 8888492128 | In distribution | ||
| 40518L | In distribution | ||
| 8887605303 | In distribution | ||
| 2816 | In distribution | ||
| 8887654088 | In distribution | ||
| 1631 | In distribution | ||
| 8888492025 | Length 16 in | In distribution | |
| 630245IC | In distribution | ||
| 40520L | In distribution | ||
| 2718 | In distribution | ||
| 402714 | In distribution | ||
| 5558492020 | Catheter Gauge 10 Fr | 250 | In distribution |
| 20518C | In distribution | ||
| 605247IC | In distribution | ||
| 23024C | Catheter Gauge 24 Fr | In distribution | |
| 8887689241 | In distribution | ||
| 5558492053 | Catheter Gauge 16 Fr | 250 | In distribution |
| 403712 | In distribution | ||
| 8887689209 | In distribution | ||
| 8887689266 | In distribution | ||
| 3601 | In distribution | ||
| 402722 | In distribution | ||
| 400618 | Catheter Gauge 18 Fr | In distribution | |
| 1619 | In distribution | ||
| 8887688169 | In distribution | ||
| 3577 | In distribution | ||
| 630229IC | In distribution | ||
| 400616 | Catheter Gauge 16 Fr | In distribution | |
| 400614 | Catheter Gauge 14 Fr | In distribution | |
| 403718 | In distribution | ||
| 403730 | In distribution | ||
| 8887664224 | In distribution | ||
| 8887664203 | In distribution | ||
| 8887689167 | In distribution | ||
| 402730 | In distribution | ||
| 8888492130 | In distribution | ||
| 403720 | In distribution | ||
| 402724 | In distribution | ||
| 50518T | Catheter Gauge 18 Fr | In distribution | |
| 2824 | In distribution | ||
| 20514ICC | In distribution | ||
| 605122IC | In distribution | ||
| 3631 | In distribution | ||
| 605148IC | In distribution | ||
| 8887689225 | In distribution | ||
| 8887649229 | In distribution | ||
| 8887648247 | In distribution | ||
| 605205IC | In distribution | ||
| 3565 | In distribution | ||
| 3623 | In distribution | ||
| 8887630305 | In distribution | ||
| 20520CW | Catheter Gauge 20 Fr | In distribution | |
| 23018CW | Catheter Gauge 18 Fr | In distribution | |
| 1616 | In distribution | ||
| 8887688268 | In distribution | ||
| 8888492120 | In distribution | ||
| 8887664182 | In distribution | ||
| 20516C | In distribution | ||
| 1416 | In distribution | ||
| 2723 | In distribution | ||
| 8887624149 | In distribution | ||
| 8888492017 | Length 16 in | In distribution | |
| 50516T | Catheter Gauge 16 Fr | In distribution | |
| 3570 | In distribution | ||
| 630203IC | In distribution | ||
| 1431 | In distribution | ||
| 400608 | Catheter Gauge 8 Fr | In distribution | |
| 3573 | In distribution | ||
| 8888492033 | Catheter Gauge 12 Fr | In distribution | |
| 8887664245 | In distribution | ||
| 1628 | In distribution | ||
| 402720 | In distribution | ||
| 8887665283 | In distribution | ||
| 8888492066 | Length 16 in | In distribution | |
| 8888492124 | In distribution | ||
| 3567 | In distribution | ||
| 3560 | In distribution | ||
| 8887654104 | In distribution | ||
| 403714 | In distribution | ||
| 403726 | In distribution | ||
| 402726 | In distribution | ||
| 403728 | In distribution | ||
| 20514C | In distribution | ||
| 3607 | In distribution | ||
| 1622 | In distribution | ||
| 8887630284 | In distribution | ||
| 403716 | In distribution | ||
| 23020C | Catheter Gauge 20 Fr | In distribution | |
| 403722 | In distribution | ||
| 23022C | Catheter Gauge 22 Fr | In distribution | |
| 1612 | In distribution | ||
| 402712 | In distribution | ||
| 8888492058 | Catheter Gauge 16 Fr | In distribution | |
| 2826 | In distribution | ||
| 402716 | In distribution | ||
| 1614 | In distribution | ||
| 8887665161 | In distribution | ||
| 8888492122 | In distribution | ||
| 1626 | In distribution | ||
| 8887688243 | In distribution | ||
| 40524L | In distribution | ||
| 3558 | In distribution | ||
| 8887689183 | In distribution | ||
| 8888492041 | Length 16 in | In distribution | |
| 1624 | In distribution | ||
| 20516ICC | In distribution | ||
| 1419 | In distribution | ||
| 8887664266 | In distribution | ||
| 8887688227 | In distribution | ||
| 40516L | In distribution | ||
| 8887660903 | Length 6.5 in | In distribution | |
| 20512ICC | In distribution | ||
| 2822 | In distribution | ||
| 20522CW | Catheter Gauge 22 Fr | In distribution | |
| 402718 | In distribution | ||
| 20524C | In distribution | ||
| 8887664287 | In distribution | ||
| 1426 | In distribution | ||
| 3611 | In distribution | ||
| 8887665262 | In distribution | ||
| 8887688201 | In distribution | ||
| 3614 | In distribution | ||
| 5558492038 | Catheter Gauge 12 Fr | 250 | Withdrawn |
| 5558492053 | Catheter Gauge 16 Fr | 250 | Withdrawn |
| 8887660903 | Catheter Gauge 14 Fr | Withdrawn | |
| 5558492046 | 250 | Withdrawn | |
| 5558492061 | Catheter Gauge 18 Fr | 250 | Withdrawn |
| 5558492012 | Catheter Gauge 8 Fr | 250 | Withdrawn |
| 23018C | Catheter Gauge 18 Fr | Withdrawn | |
| 5558492061 | Catheter Gauge 18 Fr | 250 | Withdrawn |
| 665241IC | Catheter Gauge 24 Fr | Withdrawn | |
| 5558492038 | Catheter Gauge 12 Fr | 250 | Withdrawn |
| 5558492012 | Catheter Gauge 8 Fr | 250 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Rusch | Teleflex Medical LLC | 432 |
| Dover | Cardinal Health | 152 |
| 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
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. | 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.