Urocare® Disposable Urinary Drainage Bag 64 Oz. (2,000 Ml.)
BAG, URINE COLLECTION, BED SIDE, WHEELCHAIR, DISPOSABLE, VINYL, T-TYPE DRAIN VALVE, 64 FL. OZ. (2,000 ML.) Contains/Features Include: Latex-Free, Needleless, Sterile (EO), 50" Drainage…
BAG, URINE COLLECTION, BED SIDE, WHEELCHAIR, DISPOSABLE, VINYL, T-TYPE DRAIN VALVE, 64 FL. OZ. (2,000 ML.) Contains/Features Include: Latex-Free, Needleless, Sterile (EO), 50″ Drainage Tube, Reinforced, Universal, Hanger Strap, Anti-Reflux Chamber, Needleless Sample Port, Clear Front with White Back for easy monitoring for blood or other substances in urine, Graduated Nozzle Adapter with Cap, Graduations in 100 mL. and 25 mL., Breather Patch, Bed Sheet Clip and T-Type Drain Valve.
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 | Urocare Products, 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 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-04-10 |
| Record revised | 2021-01-08 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Case of 20 |
| Sizes | Depth 1.5 in; weight 0.25 lb; height 10 in; total volume 2000 ml; width 10 in; total volume 64 Fluid Ounce |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 4200 | Depth 1.50 in | 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 |
| Medline | Medline Industries, Inc. | 19 |
| 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 |
Showing 12 of 113. All products under Collector, Urine, (And Accessories) For Indwelling Catheter
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K820565 | 1982-04-01 |
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.