GentleCathTM
Hydrophilic Intermittent Urinary Catheter With Water Sachet And Insertion Kit Tiemann 16'' 14FR
21manufacturers in China registered for this device type
32catalogue numbers in this listing
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 | Oasis Medikal Urunler Kimya Turizm Sanayi VE Ticaret Anonim Sirketi |
|---|---|
| FDA product code | EZD |
| Device type | Catheter, Straight |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5130 |
| Record published | 2016-09-23 |
| Record revised | 2024-09-02 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Keep dry |
| Packaging | Pack of 4, pack of 10, pack of 30 |
| Sizes | Length 8 to 16 in; catheter gauge 8 to 18 Fr |
| Distribution end date | 2024-08-31 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 509004 | Length 8 in | Withdrawn |
| 508998 | Catheter Gauge 18 Fr | Withdrawn |
| 509008 | Catheter Gauge 16 Fr | Withdrawn |
| 508995 | Catheter Gauge 12 Fr | Withdrawn |
| 509009 | Length 16 in | Withdrawn |
| 509001 | Length 16 in | Withdrawn |
| 508993 | Catheter Gauge 8 Fr | Withdrawn |
| 509003 | Catheter Gauge 18 Fr | Withdrawn |
| 509006 | Catheter Gauge 12 Fr | Withdrawn |
| 508994 | Catheter Gauge 10 Fr | Withdrawn |
| 509002 | Catheter Gauge 16 Fr | Withdrawn |
| 508997 | Catheter Gauge 16 Fr | Withdrawn |
| 508988 | Length 8 in | Withdrawn |
| 508999 | Catheter Gauge 10 Fr | Withdrawn |
| 508990 | Catheter Gauge 12 Fr | Withdrawn |
| 509014 | Length 16 in | Withdrawn |
| 509017 | Length 16 in | Withdrawn |
| 509016 | Length 16 in | Withdrawn |
| 508989 | Length 8 in | Withdrawn |
| 508996 | Length 16 in | Withdrawn |
| 508992 | Length 8 in | Withdrawn |
| 509013 | Catheter Gauge 16 Fr | Withdrawn |
| 509018 | Catheter Gauge 16 Fr | Withdrawn |
| 509012 | Catheter Gauge 14 Fr | Withdrawn |
| 509015 | Catheter Gauge 10 Fr | Withdrawn |
| 509011 | Length 16 in | Withdrawn |
| 509000 | Catheter Gauge 12 Fr | Withdrawn |
| 509019 | Length 16 in | Withdrawn |
| 509007 | Catheter Gauge 14 Fr | Withdrawn |
| 509005 | Length 8 in | Withdrawn |
| 509010 | Length 16 in | Withdrawn |
| 508991 | Catheter Gauge 14 Fr | Withdrawn |
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 |
| 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 |
Showing 12 of 72. All products under Catheter, Straight
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.