Wellead PVC Hydrophilic Urethral Catheter
Wellead PVC Hydrophilic Urethral Catheter is a flexible, disposable catheter for intermittent bladder drainage in people with chronic urinary retention. It is inserted through the urethra…
Wellead PVC Hydrophilic Urethral Catheter is a flexible, disposable catheter for intermittent bladder drainage in people with chronic urinary retention. It is inserted through the urethra and can be used in professional facilities or at home. The PVC tube has a polyacrylamide hydrophilic coating.
Water activates the lubricating coating before catheterization. The range includes models with an optional water sachet and models without one. Pediatric standard and female configurations are available in 6, 8 and 10 Fr sizes; larger sizes serve adult configurations.
Listed Item
without water sachet Standard Pediatric 10Fr (3.3mm)
Drainage and Single Use
Two connector shapes allow connection to a urine bag or other collection apparatus, while drainage can also go directly into a toilet. The device is supplied sterile after ethylene oxide sterilization and is intended for single use. A new intermittent catheter is used each time the bladder needs emptying.
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 | Well Lead Medical Co., Ltd., China |
|---|---|
| FDA product code | EZD |
| Device type | Catheter, Straight |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5130 |
| Establishment | Contract manufacturer, Contract steriliser, Manufacturer, Exporter |
| 510(k) | K220722 |
| Record published | 2023-11-06 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Packaging | Box of 30, carton of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| F01J072010 | In distribution | |
| F01J050810 | In distribution | |
| F01J071010 | In distribution | |
| F01J021010 | In distribution | |
| F01J021410 | In distribution | |
| F01J061010 | In distribution | |
| F01J051810 | In distribution | |
| F01J052210 | In distribution | |
| F01J061210 | In distribution | |
| F01J041410 | In distribution | |
| F01J051210 | In distribution | |
| F01J062210 | In distribution | |
| F01J051010 | In distribution | |
| F01J031210 | In distribution | |
| F01J051410 | In distribution | |
| F01J041010 | In distribution | |
| F01J050610 | In distribution | |
| F01J022010 | In distribution | |
| F01J051610 | In distribution | |
| F01J022210 | In distribution | |
| F01J041210 | In distribution | |
| F01J031810 | In distribution | |
| F01J041610 | In distribution | |
| F01J020610 | In distribution | |
| F01J032010 | In distribution | |
| F01J042210 | In distribution | |
| F01J020810 | In distribution | |
| F01J071810 | In distribution | |
| F01J031010 | In distribution | |
| F01J061610 | In distribution | |
| F01J061810 | In distribution | |
| F01J071410 | In distribution | |
| F01J031410 | In distribution | |
| F01J021210 | In distribution | |
| F01J062010 | In distribution | |
| F01J030610 | In distribution | |
| F01J060810 | In distribution | |
| F01J071610 | In distribution | |
| F01J042010 | In distribution | |
| F01J052010 | In distribution | |
| F01J060610 | In distribution | |
| F01J021810 | In distribution | |
| F01J030810 | In distribution | |
| F01J072210 | In distribution | |
| F01J041810 | In distribution | |
| F01J021610 | In distribution | |
| F01J031610 | In distribution | |
| F01J032210 | In distribution | |
| F01J071210 | In distribution | |
| F01J061410 | 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 |
| LoFric® Primo™ | Wellspect Healthcare | 48 |
| Medline | Medline Industries, Inc. | 47 |
| 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 |
|---|---|
| K220722 | 2023-05-22 |
| K142563 | 2014-10-28 |
| K133615 | 2014-02-24 |
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.