Medline
KIT,SPECI-CATH,MINI,FEMALE,8FR,PVP,GLVS
23manufacturers in China registered for this device type
5catalogue numbers in this listing
1510(k) clearance
Who Else Makes It
Concentrated in Jiangsu (10), Zhejiang (5), Guangdong (3). 4 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 |
| Flexicare Medical (Dongguan) Ltd. | Dongguan | Guangdong | Contract manufacturer | 48 |
| Anqing Kangmingna Packaging Co., Ltd. | Anqing | Anhui | Contract manufacturer | 39 |
| Conod Medical Shuyang Co., Ltd. | Shuyang | Jiangsu | Contract manufacturer | 22 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Zhejiang Mediunion Healthcare Group Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 105 |
| Sterigenics Shanghai ETO Ltd. | Shanghai | Shanghai | Contract manufacturer | 65 |
| Guangzhou Four E’s Scientific Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 61 |
| Jiangsu WLD Medical Co., Ltd. | Yizheng | Jiangsu | Contract manufacturer | 50 |
| Anhui Medpurest Medical Technology Co., Ltd. | Anqing | Anhui | Manufacturer | 46 |
| Hangzhou Fushan Medical Appliance Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 44 |
Showing 12 of 23. All 23 manufacturers in China registered for System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile
Record
| Listed by | Medline Industries, Inc., United States |
|---|---|
| FDA product code | EYZ |
| Device type | System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile |
| Device class | Class 1 |
| Regulation | 21 CFR 876.5250 |
| Premarket notification | Exempt |
| Record published | 2016-09-29 |
| Record revised | 2020-12-04 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Protect from freezing and excessive heat / shield from direct sunlight |
| Packaging | Pack of 25, pack of 10 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DYND10800 | In distribution | |
| DYND140218 | In distribution | |
| DYND140214 | In distribution | |
| DYND10806 | In distribution | |
| DYND10820 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Hollister | Hollister Incorporated | 3 |
| System, Urine Drainage, Closed, For Nonindwelling Catheter, Sterile | Domico Med-Device, LLC | 2 |
| AMD-Ritmed | AMD Medicom Inc. | 2 |
| Dover | Cardinal Health | 2 |
| SmartTap™ Paracentesis Drainage Bag, 4L | Cardiomed Supplies Inc | 1 |
| Endure Industries | Endure Industries, Inc. | 1 |
| EZ-Flow Catheter Valve | Flexicare Medical Ltd. | 1 |
| SmartTap™ Paracentesis Drainage Bag, 2L | Cardiomed Supplies Inc | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K896695 | 1990-05-02 |
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.