Cure Catheter® Closed System
Closed System Complete Urinary Catheterization System with Catheter Control Feature, Straight Tip
11manufacturers in China registered for this device type
17catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (6), Zhejiang (5). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amsino Medical (Kunshan) Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 53 |
| Conod Medical Co., Limited | Changshu | Jiangsu | Contract manufacturer | 48 |
| Shaoxing Jiancheng Medical Products Co., Ltd. | Shaoxing | Zhejiang | Contract manufacturer | 9 |
| Integral Medical Products Co., Ltd. | Shaoxing | Zhejiang | Contract manufacturer | 7 |
| Shaoxing Fuqing Health Products Co., Ltd. | Shaoxing | Zhejiang | Contract manufacturer | 3 |
| Changshu Rozer Sterilization Technology Co., Ltd. | Changshu | Jiangsu | Contract manufacturer | 43 |
| Joykey Industrial (Pinghu) Limited | Pinghu | Zhejiang | Contract manufacturer | 43 |
| Rozer Sterilization Technology Shuyang Company Limited | Shuyang | Jiangsu | Contract manufacturer | 33 |
| Nanjing Anjian Medical Device Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 22 |
| Suzhou Prosteri Medical Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 20 |
| Integral Sterilization Technology (Shaoxing) Co., Ltd. | Shaoxing | Zhejiang | Contract manufacturer | 5 |
Record
| Listed by | Convatec, Purchasing Department |
|---|---|
| FDA product code | FCM |
| Device type | Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5130 |
| 510(k) | K080881 |
| Record published | 2017-12-31 |
| Record revised | 2023-05-23 (version 7) |
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 |
| Packaging | Case of 100 |
| Sizes | Catheter gauge 8 to 16 Fr |
| Distribution end date | 2022-02-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CS10 | Catheter Gauge 10 Fr | In distribution |
| CS14 | Catheter Gauge 14 Fr | In distribution |
| CS12 | Catheter Gauge 12 Fr | In distribution |
| CS14C | Catheter Gauge 14 Fr | In distribution |
| CS8 | Catheter Gauge 8 Fr | In distribution |
| CSL10 | Catheter Gauge 10 Fr | Withdrawn |
| CS8BZK | Catheter Gauge 8 Fr | Withdrawn |
| CSL14C | Catheter Gauge 14 Fr | Withdrawn |
| CSL16 | Catheter Gauge 16 Fr | Withdrawn |
| CS10BZK | Catheter Gauge 10 Fr | Withdrawn |
| CSL8 | Catheter Gauge 8 Fr | Withdrawn |
| CS16BZK | Catheter Gauge 16 Fr | Withdrawn |
| CSL14 | Catheter Gauge 14 Fr | Withdrawn |
| CSL12 | Catheter Gauge 12 Fr | Withdrawn |
| CS14BZK | Catheter Gauge 14 Fr | Withdrawn |
| CS12BZK | Catheter Gauge 12 Fr | Withdrawn |
| CS14BZKC | Catheter Gauge 14 Fr | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Dover | Cardinal Health | 72 |
| Dover | Cardinal Health 200, LLC | 55 |
| Gentlecath | Convatec, Purchasing Department | 28 |
| AMSure® Foley Catheter Tray | Amsino Medical Inc. | 26 |
| Medline Industries, Inc. | Medline Industries, Inc. | 20 |
| Self-Cath Closed System | Coloplast A/S | 20 |
| Nurse Assist | Nurse Assist, LLC | 17 |
| Bard® Touchless® Plus Unisex Pre-Lubricated Vinyl Urethral Catheter | C.R. Bard, Inc. | 13 |
| Apogee Plus | Hollister Incorporated | 12 |
| Advance Plus | Hollister Incorporated | 9 |
| AMSure ® Foley Catheters Tray | Amsino Medical Inc. | 9 |
| Medline | Medline Industries, Inc. | 8 |
Showing 12 of 45. All products under Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)
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.