Gentlecath
CVT Gentlecath IC Cath Insert Supplies KIT
11manufacturers in China registered for this device type
28catalogue 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) | K010420 |
| Record published | 2016-09-09 |
| Record revised | 2022-05-23 (version 10) |
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 |
| Packaging | Case of 100, pack of 100 |
| Distribution end date | 2022-05-20 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 421428 | 08 FR | Withdrawn |
| 421414 | 12 FR | Withdrawn |
| 421415 | 14 FR | Withdrawn |
| 421430 | 12 FR | Withdrawn |
| 421421 | 14 FR | Withdrawn |
| 421439 | 14 FR | Withdrawn |
| 421423 | 12 FR | Withdrawn |
| 421417 | 18 FR | Withdrawn |
| 421425 | 16 FR | Withdrawn |
| 421432 | 16 FR | Withdrawn |
| 421436 | 14 FR | Withdrawn |
| 421412 | 08 FR | Withdrawn |
| 421416 | 16 FR | Withdrawn |
| 421422 | 16 FR | Withdrawn |
| 421427 | 14 FR | Withdrawn |
| 421431 | 14 FR | Withdrawn |
| 421426 | 14 FR | Withdrawn |
| 421411 | 06 FR | Withdrawn |
| 421429 | 10 FR | Withdrawn |
| 421434 | 14 FR | Withdrawn |
| 421420 | 12 FR | Withdrawn |
| 503870 | Withdrawn | |
| 421437 | 16 FR | Withdrawn |
| 421413 | 10 FR | Withdrawn |
| 421433 | 12 FR | Withdrawn |
| 421418 | 12 FR | Withdrawn |
| 421424 | 14 FR | Withdrawn |
| 421419 | 14 FR | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Dover | Cardinal Health | 72 |
| Dover | Cardinal Health 200, LLC | 55 |
| AMSure® Foley Catheter Tray | Amsino Medical Inc. | 26 |
| Medline Industries, Inc. | Medline Industries, Inc. | 20 |
| Self-Cath Closed System | Coloplast A/S | 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)
Recalls Naming This Product
3 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Teleflex Medical LLC | 510(k) number | 2022-09-20 | Class II | Nonconforming Material/Component | Product may not be sterile | 7200 catheters | |
| Teleflex Medical LLC | 510(k) number | 2016-11-22 | Class II | Error in labeling | Labeling Inconsistency: The products have been labeled with the incorrect expiration date which exceeds the actual, validated 35-month shelf life. | 102,843 units | 2017-11-24 |
| Teleflex Medical LLC | 510(k) number | 2005-07-11 | Not classified | Other | There is a lack of assurance of sterility for parts of these lots of product. | 95,800 units | 2007-11-14 |
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.