TruCath
TruCath® Silicone Elastomer Coated Latex Foley Catheter, Coudé Tip, 16 Fr 5 ml, 2-Way
17manufacturers in China registered for this device type
59catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (5), Zhejiang (4), Guangdong (3). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dongguan BAO Kang Dian ZI KE JI Limited | Dongguan | Guangdong | Contract manufacturer | 24 |
| Primecare Medical (Suzhou) Co., Ltd. | Changshu | Jiangsu | Contract manufacturer | 20 |
| Haiyan Kangyuan Medical Instrument Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 17 |
| Primecare Medical (Huzhou) Co., Ltd. | Hu Zhou | Zhejiang | Contract manufacturer | 9 |
| Bioxin Medical Co., Ltd. | Weihai | Shandong | Contract manufacturer | 8 |
| Well Lead Medical (Hainan) Co., Ltd. | Haikou | Hainan | Contract manufacturer | 3 |
| Amsino Medical (Kunshan) Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 53 |
| Well Lead Medical Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 46 |
| Hangzhou Fushan Medical Appliance Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 44 |
| Changshu Rozer Sterilization Technology Co., Ltd. | Changshu | Jiangsu | Contract manufacturer | 43 |
| Hangzhou Primecare Medical Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 29 |
| Amsino Medical (Shanghai) Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 22 |
Showing 12 of 17. All 17 manufacturers in China registered for Catheter, Retention Type, Balloon
Record
| Listed by | HR Pharmaceuticals Inc. |
|---|---|
| FDA product code | EZL |
| Device type | Catheter, Retention Type, Balloon |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5130 |
| Record published | 2024-02-01 |
| Record revised | 2024-03-27 (version 2) |
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 | Special storage condition: Storage Humiditiy = 95%; Storage environment temperature 0 to 49 °C |
| Packaging | Case of 50, box of 12, box of 10, case of 10 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SS22303W | In distribution | |
| LS1610 | In distribution | |
| LS2410 | In distribution | |
| LS24303W | In distribution | |
| SS18303W | In distribution | |
| LS2030 | In distribution | |
| LS1830 | In distribution | |
| TS1410 | In distribution | |
| SS1210 | In distribution | |
| LS16303W | In distribution | |
| D10018 | In distribution | |
| SS0603 | In distribution | |
| SS2010 | In distribution | |
| SS2410 | In distribution | |
| SS16303W | In distribution | |
| SS2230 | In distribution | |
| SS2210 | In distribution | |
| TS1005 | In distribution | |
| LC1610 | In distribution | |
| LS1630 | In distribution | |
| LS20303W | In distribution | |
| D10020 | In distribution | |
| TS1610 | In distribution | |
| LS22303W | In distribution | |
| D10022 | In distribution | |
| LS18303W | In distribution | |
| SC1810 | In distribution | |
| TS0805 | In distribution | |
| TS1810 | In distribution | |
| SS1610 | In distribution | |
| SS2430 | In distribution | |
| SS0805 | In distribution | |
| LS26303W | In distribution | |
| SS2030 | In distribution | |
| LC2410 | In distribution | |
| LS2010 | In distribution | |
| SC2010 | In distribution | |
| SS24303W | In distribution | |
| SS1630 | In distribution | |
| TS1210 | In distribution | |
| SC1610 | In distribution | |
| SC1410 | In distribution | |
| D10016 | In distribution | |
| SS1830 | In distribution | |
| LC2210 | In distribution | |
| LS2430 | In distribution | |
| LC1410 | In distribution | |
| SS1005 | In distribution | |
| LS1810 | In distribution | |
| LS1410 | In distribution | |
| LS1210 | In distribution | |
| SS1410 | In distribution | |
| LC1810 | In distribution | |
| SS1810 | In distribution | |
| LC2010 | In distribution | |
| LS2210 | In distribution | |
| SS20303W | In distribution | |
| D10014 | In distribution | |
| LS2230 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| All Silicone Foley Catheter | Well Lead Medical Co., Ltd. | 175 |
| Dover | Cardinal Health 200, LLC | 85 |
| Dover | Cardinal Health | 82 |
| Rusch | Teleflex Medical LLC | 79 |
| Porges Coloplast | Coloplast A/S | 74 |
| Medline | Medline Industries, Inc. | 72 |
| McKesson | Mckesson Medical-Surgical Inc. | 63 |
| Folysil | Coloplast A/S | 47 |
| Sunmed | SunMed Group Holdings, LLC | 35 |
| Universa | Cook Incorporated | 31 |
| AMSure ® Hydrophilic Latex Foley Catheters | Amsino Medical Inc. | 31 |
| AMSure® Silicone Coated Latex Foley Catheter | Amsino Medical Inc. | 28 |
Showing 12 of 135. All products under Catheter, Retention Type, Balloon
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.