Rusch
SoftSimplastic 3 Way Foley Couvelaire Tip Catheter
17manufacturers in China registered for this device type
79catalogue 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 | Teleflex Medical LLC, United States |
|---|---|
| FDA product code | EZL |
| Device type | Catheter, Retention Type, Balloon |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5130 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K972184 |
| Record published | 2016-09-16 |
| Record revised | 2025-03-18 (version 11) |
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, manufacturing date |
| Storage | Special storage condition: Keep dry; Keep away from sunlight |
| Packaging | Box of 10, case of 10, box of 5, case of 12, carton of 12, carton of 72 |
| Sizes | Outer diameter 2 to 8.7 mm; catheter gauge 16 to 24 Fr; outer diameter 0.209 to 0.315 in |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IPN050269 | Outer Diameter 4 mm | In distribution |
| IPN052897 | Outer Diameter 8 mm | In distribution |
| IPN052894 | Outer Diameter 6 mm | In distribution |
| IPN054277 | Outer Diameter 5.3 mm | In distribution |
| IPN052933 | Outer Diameter 6.7 mm | In distribution |
| IPN054282 | Outer Diameter 6 mm | In distribution |
| IPN054272 | Outer Diameter 5.3 mm | In distribution |
| IPN050316 | Catheter Gauge 18 Fr | In distribution |
| IPN915202 | Outer Diameter 0.209 in | In distribution |
| IPN054281 | Outer Diameter 8 mm | In distribution |
| IPN054276 | Outer Diameter 8 mm | In distribution |
| IPN052892 | Outer Diameter 4.7 mm | In distribution |
| IPN052893 | Outer Diameter 5.3 mm | In distribution |
| IPN915206 | Outer Diameter 0.315 in | In distribution |
| IPN052927 | Outer Diameter 5.3 mm | In distribution |
| IPN050273 | Outer Diameter 6.7 mm | In distribution |
| IPN050150 | Outer Diameter 6.7 mm | In distribution |
| IPN054279 | Outer Diameter 6.7 mm | In distribution |
| IPN050127 | Outer Diameter 2.7 mm | In distribution |
| IPN050175 | Outer Diameter 7.3 mm | In distribution |
| IPN054267 | Outer Diameter 5.3 mm | In distribution |
| IPN054275 | Outer Diameter 7.3 mm | In distribution |
| IPN054274 | Outer Diameter 6.7 mm | In distribution |
| IPN915203 | Outer Diameter 0.237 in | In distribution |
| IPN050148 | Outer Diameter 6 mm | In distribution |
| IPN052898 | Outer Diameter 5.3 mm | In distribution |
| IPN050125 | Outer Diameter 2 mm | In distribution |
| IPN050173 | Outer Diameter 6.7 mm | In distribution |
| IPN050179 | Outer Diameter 8.7 mm | In distribution |
| IPN050271 | Outer Diameter 5.3 mm | In distribution |
| IPN050270 | Outer Diameter 4.7 mm | In distribution |
| IPN052931 | Outer Diameter 8 mm | In distribution |
| IPN052896 | Outer Diameter 7.3 mm | In distribution |
| IPN052932 | Outer Diameter 6 mm | In distribution |
| IPN050151 | Outer Diameter 7.3 mm | In distribution |
| IPN054280 | Outer Diameter 7.3 mm | In distribution |
| IPN052902 | Outer Diameter 8 mm | In distribution |
| IPN050319 | Catheter Gauge 24 Fr | In distribution |
| IPN050275 | Outer Diameter 8 mm | In distribution |
| IPN050155 | Outer Diameter 8.7 mm | In distribution |
| IPN915205 | Outer Diameter 0.288 in | In distribution |
| IPN050153 | Outer Diameter 8 mm | In distribution |
| IPN052935 | Outer Diameter 8 mm | In distribution |
| IPN052901 | Outer Diameter 7.3 mm | In distribution |
| IPN052900 | Outer Diameter 6.7 mm | In distribution |
| IPN050169 | Outer Diameter 5.3 mm | In distribution |
| IPN050329 | Outer Diameter 7.3 mm | In distribution |
| IPN053899 | Outer Diameter 5.3 mm | In distribution |
| IPN052928 | Outer Diameter 6 mm | In distribution |
| IPN050325 | Outer Diameter 6 mm | In distribution |
| IPN050144 | Outer Diameter 4.7 mm | In distribution |
| IPN915204 | Outer Diameter 0.264 in | In distribution |
| IPN050146 | Outer Diameter 5.3 mm | In distribution |
| IPN050177 | Outer Diameter 8 mm | In distribution |
| IPN054266 | Outer Diameter 4.7 mm | In distribution |
| IPN052929 | Outer Diameter 6.7 mm | In distribution |
| IPN054270 | Outer Diameter 7.3 mm | In distribution |
| IPN050327 | Outer Diameter 6.7 mm | In distribution |
| IPN050274 | Outer Diameter 7.3 mm | In distribution |
| IPN054278 | Outer Diameter 6 mm | In distribution |
| IPN050318 | Catheter Gauge 22 Fr | In distribution |
| IPN050331 | Outer Diameter 8 mm | In distribution |
| IPN052934 | Outer Diameter 7.3 mm | In distribution |
| IPN054269 | Outer Diameter 6.7 mm | In distribution |
| IPN054285 | Outer Diameter 8 mm | In distribution |
| IPN054284 | Outer Diameter 7.3 mm | In distribution |
| IPN054283 | Outer Diameter 6.7 mm | In distribution |
| IPN054268 | Outer Diameter 6 mm | In distribution |
| IPN050129 | Outer Diameter 3.3 mm | In distribution |
| IPN050142 | Outer Diameter 4 mm | In distribution |
| IPN054271 | Outer Diameter 8 mm | In distribution |
| IPN054273 | Outer Diameter 6 mm | In distribution |
| IPN050317 | Catheter Gauge 20 Fr | In distribution |
| IPN052895 | Outer Diameter 6.7 mm | In distribution |
| IPN050272 | Outer Diameter 6 mm | In distribution |
| IPN052899 | Outer Diameter 6 mm | In distribution |
| IPN050315 | Catheter Gauge 16 Fr | In distribution |
| IPN050171 | Outer Diameter 6 mm | In distribution |
| IPN052930 | Outer Diameter 7.3 mm | 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 |
| Porges Coloplast | Coloplast A/S | 74 |
| Medline | Medline Industries, Inc. | 72 |
| McKesson | Mckesson Medical-Surgical Inc. | 63 |
| TruCath | HR Pharmaceuticals Inc. | 59 |
| 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.