Rusch
Catalogue number 76000, listed by Teleflex Medical LLC, United States, under Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit). 11 manufacturers in China are registered for this product code.
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 | Teleflex Medical LLC, United States |
|---|---|
| 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, Complaint-file establishment, Manufacturer |
| 510(k) | K010420 |
| Record published | 2026-05-12 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, manufacturing date |
| Packaging | Case of 100 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 76000 | 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 |
| 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 |
Showing 12 of 45. All products under Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)
Recalls Naming This Product
1 recall names this product by its own identifier, 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 | 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 |
Recalls
1 of these is Class III. Class III is unlikely to cause harm at all → typically a labelling or documentation fault. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2014-07-10 | Class III | Process control | Labeling error: The manufacturing date is the same as the expiration date. The manufacturing date is correct, however the expiration date incorrectly indicates that the product is expired. | 720 | 2015-11-25 |
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.