DeRoyal
Foley Temp Catheter w/ Urine Meter
11manufacturers in China registered for this device type
5catalogue numbers in this listing
1510(k) clearance
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 | Deroyal Industries, Inc., 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 | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Record published | 2016-09-12 |
| Record revised | 2020-12-04 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 10, case of 2, case of 8 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 81-080518 | In distribution | |
| 94-0268 | In distribution | |
| 89-8655 | In distribution | |
| 81-080514 | In distribution | |
| 81-080516 | 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)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K951178 | 1995-04-21 |
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.