Self-Cath Closed System
Self-Cath Closed System Kit. Straight Tip. Female. Pre-lubricated Urinary Catheterization System. Contents: Coloplast Self-Cath urethral catheter FR 14, 1100 cc collection bag, 3…
Self-Cath Closed System Kit. Straight Tip. Female. Pre-lubricated Urinary Catheterization System. Contents: Coloplast Self-Cath urethral catheter FR 14, 1100 cc collection bag, 3 Povidone-Iodine swabsticks, Benzalkonium Chloride towelette, Gloves and Underpad. Rx only.
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 | Coloplast A/S, Denmark |
|---|---|
| FDA product code | FCM |
| Device type | Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit) |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5130 |
| Establishment | Specification developer, Manufacturer |
| Record published | 2016-09-02 |
| Record revised | 2024-10-07 (version 6) |
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: Do not use if package is damaged and consult IFU. |
| Packaging | Shipper box of 50 |
| Sizes | Catheter gauge 8 to 16 Fr; catheter working length 5.2 to 12.2 in; catheter working length 13 to 31 cm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 50281 | Catheter Gauge 14 Fr | In distribution |
| 50285 | Catheter Gauge 14 Fr | In distribution |
| 50290 | Catheter Gauge 14 Fr | In distribution |
| 50293 | Catheter Gauge 14 Fr | In distribution |
| 50263 | Catheter Gauge 14 Fr | In distribution |
| 50277 | Catheter Gauge 14 Fr | In distribution |
| 50264 | Catheter Gauge 16 Fr | In distribution |
| 50270 | Catheter Gauge 8 Fr | In distribution |
| 50286 | Catheter Gauge 14 Fr | In distribution |
| 50272 | Catheter Gauge 12 Fr | In distribution |
| 50261 | Catheter Gauge 10 Fr | In distribution |
| 50260 | Catheter Gauge 8 Fr | In distribution |
| 50274 | Catheter Gauge 16 Fr | In distribution |
| 50298 | Catheter Gauge 16 Fr | In distribution |
| 50262 | Catheter Gauge 12 Fr | In distribution |
| 50296 | Catheter Gauge 14 Fr | In distribution |
| 50273 | Catheter Gauge 14 Fr | In distribution |
| 50297 | Catheter Gauge 14 Fr | In distribution |
| 50287 | Catheter Gauge 16 Fr | In distribution |
| 50271 | Catheter Gauge 10 Fr | In distribution |
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 |
| Cure Catheter® Closed System | Convatec, Purchasing Department | 17 |
| 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.