Universa
Universa, Silicone Foley Catheter Wire Guide With Hydrophilic Coating
17manufacturers in China registered for this device type
31catalogue numbers in this listing
1510(k) clearance
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 | Cook Incorporated, United States |
|---|---|
| FDA product code | EZL |
| Device type | Catheter, Retention Type, Balloon |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5130 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2016-09-24 |
| Record revised | 2020-12-04 (version 8) |
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 |
| Storage | Special storage condition: Store in dark, dry, cool place. |
| Packaging | Pack of 12, pack of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| G17199 | In distribution | |
| G53235 | In distribution | |
| G17214 | In distribution | |
| G53242 | In distribution | |
| G53030 | In distribution | |
| G17208 | In distribution | |
| G17198 | In distribution | |
| G32767 | In distribution | |
| G32766 | In distribution | |
| G17345 | In distribution | |
| G53246 | In distribution | |
| G53245 | In distribution | |
| G32765 | In distribution | |
| G17206 | In distribution | |
| G53243 | In distribution | |
| G17202 | In distribution | |
| G17512 | In distribution | |
| G17200 | In distribution | |
| G17204 | In distribution | |
| G17205 | In distribution | |
| G53244 | In distribution | |
| G53241 | In distribution | |
| G53237 | In distribution | |
| G32764 | In distribution | |
| G17111 | In distribution | |
| G17203 | In distribution | |
| G17201 | In distribution | |
| G53236 | In distribution | |
| G53240 | In distribution | |
| G53238 | In distribution | |
| G17207 | 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 |
| TruCath | HR Pharmaceuticals Inc. | 59 |
| Folysil | Coloplast A/S | 47 |
| Sunmed | SunMed Group Holdings, LLC | 35 |
| 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K173657 | 2018-08-23 |
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.