Medline
Straight TIP 12FR 16" Hydrophilic Coated
21manufacturers in China registered for this device type
47catalogue numbers in this listing
2510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (9), Zhejiang (7), Shanghai (2). 9 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Conod Medical Co., Limited | Changshu | Jiangsu | Contract manufacturer | 48 |
| Well Lead Medical Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 46 |
| Conod Medical Shuyang Co., Ltd. | Shuyang | Jiangsu | Contract manufacturer | 22 |
| Suzhou Jingle Polymer Medical Apparatus Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Haiyan Kangyuan Medical Instrument Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 17 |
| Jiangsu Suyun Medical Materials Co., Ltd. | Lianyungang | Jiangsu | Contract manufacturer | 11 |
| Integral Medical Products Co., Ltd. | Shaoxing | Zhejiang | Contract manufacturer | 7 |
| Shaoxing Fuqing Health Products Co., Ltd. | Shaoxing | Zhejiang | Contract manufacturer | 3 |
| Xianju Bever Medical Devices Co., Ltd. | Taizhou | Zhejiang | Contract manufacturer | 3 |
| Sterigenics Shanghai ETO Ltd. | Shanghai | Shanghai | Contract manufacturer | 65 |
| Amsino Medical (Kunshan) Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 53 |
| Changshu Rozer Sterilization Technology Co., Ltd. | Changshu | Jiangsu | Contract manufacturer | 43 |
Showing 12 of 21. All 21 manufacturers in China registered for Catheter, Straight
Record
| Listed by | Medline Industries, Inc., United States |
|---|---|
| FDA product code | EZD |
| Device type | Catheter, Straight |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5130 |
| 510(k) | K220722 |
| Record published | 2016-10-14 |
| Record revised | 2026-05-08 (version 5) |
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 | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Label does not mention Storage Conditions |
| Packaging | Case of 30, pack of 30, case of 25, pack of 100 |
| Sizes | Catheter gauge 14 Fr |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| URO3PVC1216C | In distribution | |
| DYND10702 | In distribution | |
| UR4PVC1006L | In distribution | |
| UR4PVC1216L | In distribution | |
| UR4PVC1216LC | In distribution | |
| UR4PVC0806L | In distribution | |
| UR4PVC1606L | In distribution | |
| DYND10703 | In distribution | |
| DYND10721 | In distribution | |
| URO3PVC1816L | In distribution | |
| UR4PVC1616L | In distribution | |
| UR4PVC1806L | In distribution | |
| URO3PVC1416C | In distribution | |
| DYND10713 | In distribution | |
| UR4PVC1610L | In distribution | |
| DYND10722 | In distribution | |
| UR4PVC0810L | In distribution | |
| UR4PVC1416LC | In distribution | |
| UR4PVC1410L | In distribution | |
| UR4PVC1016LC | In distribution | |
| DYND10724 | In distribution | |
| DYND10805F | In distribution | |
| URO3PVC1816C | In distribution | |
| DYND10810 | In distribution | |
| UR4PVC0816LC | In distribution | |
| URO3PVC1616C | In distribution | |
| UR4PVC1616LC | In distribution | |
| URO3PVC1416L | Catheter Gauge 14 Fr | In distribution |
| UR4PVC0816L | In distribution | |
| UR4PVC1406L | In distribution | |
| URO3PVC1216L | In distribution | |
| UR4PVC1206L | In distribution | |
| UR4PVC1816L | In distribution | |
| UR4PVC1816LC | In distribution | |
| DYND10725 | In distribution | |
| DYND10712 | In distribution | |
| DYND10723 | In distribution | |
| UR4PVC1416L | In distribution | |
| UR4PVC1016L | In distribution | |
| DYND10805 | In distribution | |
| URO3PVC1616L | In distribution | |
| URO3PVC1016L | In distribution | |
| URO3PVC1016C | In distribution | |
| UR4PVC1010L | In distribution | |
| DYND10700 | In distribution | |
| UR4PVC1810L | In distribution | |
| UR4PVC1210L | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Disposable intermittent catheter (TPU Catheter) | Chengdu Daxan Innovative Medical Tech. Co., Ltd. | 140 |
| LoFric® Hydro-Kit™ | Wellspect Healthcare | 57 |
| LoFric® | Wellspect Healthcare | 56 |
| SimPro™ Now | Wellspect Healthcare | 55 |
| Self-Cath | Coloplast A/S | 50 |
| Wellead PVC Hydrophilic Urethral Catheter | Well Lead Medical Co., Ltd. | 50 |
| LoFric® Primo™ | Wellspect Healthcare | 48 |
| Halyard | Owens & Minor Distribution, Inc. | 39 |
| Cure Catheter | Convatec, Purchasing Department | 39 |
| AMSure® PVC Intermittent Catheter | Amsino Medical Inc. | 39 |
| LoFric® Origo™ | Wellspect Healthcare | 34 |
| PVC Hydrophilic Urethral Catheter | Chengdu Daxan Innovative Medical Tech. Co., Ltd. | 32 |
Showing 12 of 72. All products under Catheter, Straight
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K172541 | 2018-02-22 |
| K100302 | 2010-07-02 |
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.