Medline
DBD-Centrad Only,covered BAG,UROL,2000ML
51manufacturers in China registered for this device type
19catalogue numbers in this listing
4510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (25), Zhejiang (9), Shanghai (5). 9 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 |
| Suzhou Jingle Polymer Medical Apparatus Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 19 |
| Sino Protection (Hefei) Medical Products Co., Ltd. | Hefei | Anhui | Contract manufacturer | 18 |
| Hitec Medical Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 17 |
| Forefront Medical Technology (Jiangsu) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 14 |
| Heyuan Hong DE Medical Products Co., Ltd. | Heyuan | Guangdong | Contract manufacturer | 13 |
| Meifu Medical Technology Suzhou Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 13 |
| Primecare Medical (Huzhou) Co., Ltd. | Hu Zhou | Zhejiang | Contract manufacturer | 9 |
| Anhui Careplus Medical Technology Co., Ltd. | Xuancheng | Anhui | Contract manufacturer | 6 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Huzhou Junda Industry Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 129 |
Showing 12 of 51. All 51 manufacturers in China registered for Collector, Urine, (And Accessories) For Indwelling Catheter
Record
| Listed by | Medline Industries, Inc., United States |
|---|---|
| FDA product code | KNX |
| Device type | Collector, Urine, (And Accessories) For Indwelling Catheter |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5250 |
| Premarket notification | Exempt |
| Record published | 2020-11-12 |
| Record revised | 2021-04-07 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Label does not mention Storage Conditions |
| Packaging | Case of 20, case of 48, pack of 48, pack of 20, pack of 12 |
| Sizes | Total volume 32 Fluid Ounce; total volume 2000 ml |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| DYNC1674 | In distribution | |
| DYND25205 | In distribution | |
| URO5458 | In distribution | |
| DYND25405S | In distribution | |
| URO12573 | Total Volume 32 Fluid Ounce | In distribution |
| DYND12584 | In distribution | |
| DYND12578 | In distribution | |
| DYND12588 | In distribution | |
| DYND12575 | In distribution | |
| DYND15215 | In distribution | |
| UROT51211C | In distribution | |
| UROECLIPSE | In distribution | |
| DYND15203 | In distribution | |
| DYND15405 | In distribution | |
| URO5454 | In distribution | |
| DYND15207 | In distribution | |
| URO25205V | Total Volume 2000 ml | In distribution |
| DYND15205 | In distribution | |
| URO51211C | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Dover | Cardinal Health | 71 |
| Urine Bag | Well Lead Medical Co., Ltd. | 64 |
| Dover | Cardinal Health 200, LLC | 53 |
| Rusch | Teleflex Medical LLC | 10 |
| Bard® Urine Meter with Bag | C.R. Bard, Inc. | 10 |
| Bard® Add-A-Foley Tray | C.R. Bard, Inc. | 10 |
| AMSure® Urinary Drainage Bag | Amsino Medical Inc. | 8 |
| Bard® Urinary Drainage Bag with Anti-Reflux Chamber | C.R. Bard, Inc. | 6 |
| Bard® Urinary Drainage Bag | C.R. Bard, Inc. | 6 |
| Uro-Safe® Disposable Vinyl Leg Bag 18 oz. (550 mL.) | Urocare Products, Inc. | 6 |
| Medline Industries, Inc. | Medline Industries, Inc. | 5 |
| SureStep™ Foley Tray System Complete Care® Add-A-Foley Catheter | C.R. Bard, Inc. | 5 |
Showing 12 of 113. All products under Collector, Urine, (And Accessories) For Indwelling Catheter
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K972887 | 1997-12-11 |
| K896688 | 1990-05-02 |
| K832822 | 1983-10-14 |
| K791969 | 1979-11-05 |
Recalls Naming This Product
2 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Medline Industries, LP – Northfield | UDI-DI | 2023-10-19 | Class II | Labeling mix-ups | Undeclared latex | 19406 devices |
| Medline Industries, LP – Northfield | UDI-DI | 2023-10-19 | Class II | Labeling mix-ups | Undeclared latex | 144 devices |
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.