MTG
14fr 16" COUDE Closed System Catheter Kit, Sample port 1500ml collection bag, std size BZK swabs
9manufacturers in China registered for this device type
59catalogue 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 | HR Pharmaceuticals Inc. |
|---|---|
| FDA product code | KOD |
| Device type | Catheter, Urological |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5130 |
| 510(k) | K080878 |
| Record published | 2022-09-28 |
| Record revised | 2026-03-27 (version 3) |
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 | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Case of 100, case of 50 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 12116 | In distribution | |
| 42412 | In distribution | |
| 42114 | In distribution | |
| 20114 | In distribution | |
| 30110 | In distribution | |
| 32114SP | In distribution | |
| 52812 | In distribution | |
| 32112 | In distribution | |
| 32612 | In distribution | |
| 32112SP | In distribution | |
| 22612 | In distribution | |
| 22614 | In distribution | |
| 52116 | In distribution | |
| 50814 | In distribution | |
| 32110 | In distribution | |
| 20614 | In distribution | |
| 32510 | In distribution | |
| 32212 | In distribution | |
| 42414 | In distribution | |
| 12112 | In distribution | |
| 42112 | In distribution | |
| 50116 | In distribution | |
| 40414 | In distribution | |
| 32116 | In distribution | |
| 22114 | In distribution | |
| 40412 | In distribution | |
| 32108 | In distribution | |
| 22116 | In distribution | |
| 20612 | In distribution | |
| 52112 | In distribution | |
| 22716 | In distribution | |
| 50114 | In distribution | |
| 22714 | In distribution | |
| 12114 | In distribution | |
| 21114 | In distribution | |
| 30114 | In distribution | |
| 30112 | In distribution | |
| 20116 | In distribution | |
| 32614SP | In distribution | |
| 42116 | In distribution | |
| 32616 | In distribution | |
| 31114 | In distribution | |
| 32214 | In distribution | |
| 32612SP | In distribution | |
| 32116SP | In distribution | |
| 22616 | In distribution | |
| 32508 | In distribution | |
| 30108 | In distribution | |
| 40114 | In distribution | |
| 22712 | In distribution | |
| 50816 | In distribution | |
| 32616SP | In distribution | |
| 20112 | In distribution | |
| 52114 | In distribution | |
| 50112 | In distribution | |
| 32114 | In distribution | |
| 50812 | In distribution | |
| 32614 | In distribution | |
| 22112 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Rusch | Teleflex Medical LLC | 432 |
| Dover | Cardinal Health 200, LLC | 163 |
| Dover | Cardinal Health | 152 |
| 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
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.