Urocare® Reusable Latex Leg Bag 16 Oz. (500 Ml.)
BAG, URINE COLLECTION, LEG, REUSABLE, LATEX, ODOR BARRIER, STRAPS, SPORT-LEFT LARGE, 16 FL. OZ. (500 ML.) Contains: Standard Top Adapter #6002, Latex Leg Bag with Odor Barrier, Standard…
BAG, URINE COLLECTION, LEG, REUSABLE, LATEX, ODOR BARRIER, STRAPS, SPORT-LEFT LARGE, 16 FL. OZ. (500 ML.) Contains: Standard Top Adapter #6002, Latex Leg Bag with Odor Barrier, Standard Bottom Drain Valve #6004, Latex Leg Straps with Buttons #6006 and Illustrated Use and Care Instructions.
Who Else Makes It
Concentrated in Jiangsu (19), Anhui (7), Zhejiang (6). 6 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Conod Medical Co., Limited | Changshu | Jiangsu | Contract manufacturer | 48 |
| Conod Medical Shuyang Co., Ltd. | Shuyang | Jiangsu | Contract manufacturer | 22 |
| Changzhou Recoo Healthcare Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 19 |
| Clinisupplies (Nanjing) Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 13 |
| Shenzhen Giftshine Technology Co Ltd | Shenzhen | Guangdong | Contract manufacturer | 5 |
| Velcro (China) Fastening Systems Company Limited | Zhangjiagang | Jiangsu | Contract manufacturer | 3 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
| Zhejiang Lidesen Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 100 |
| Shanghai Jolly Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 99 |
| Shanghai Lions Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 82 |
Showing 12 of 47. All 47 manufacturers in China registered for Bag, Urine Collection, Leg, For External Use, Non-Sterile
Record
| Listed by | Urocare Products, Inc., United States |
|---|---|
| FDA product code | NNW |
| Device type | Bag, Urine Collection, Leg, For External Use, Non-Sterile |
| Device class | Class 1 |
| Regulation | 21 CFR 876.5250 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-04-06 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Over the counter | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Sizes | Total volume 16 Fluid Ounce; total volume 500 ml; width 10 in; weight 0.34 lb; height 5.75 in; depth 1 in |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 8516 | Total Volume 16 Fluid Ounce | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Allen | Hill-ROM, Inc. | 8 |
| Kova Plastics | Alltrista Plastics LLC | 7 |
| Hollister | Hollister Incorporated | 4 |
| TIDIShield | Tidi Products, LLC | 3 |
| Conveen Security+ | Coloplast A/S | 3 |
| Bag, Urine Collection, Leg, For External Use, Non-Sterile | David Scott Company. | 3 |
| Coulmed | Coulmed Products Group LLC | 2 |
| Conveen | Coloplast A/S | 2 |
| Conveen Contour | Coloplast A/S | 2 |
| Extension Tubing | C.R. Bard, Inc. | 2 |
| Acosta Uro-Gard | Acosta Medical Group Inc. | 2 |
| Urocare® Tubing Clear-Vinyl with Nozzle Adapter & Cap 0.28″ ID x 8.5″ | Urocare Products, Inc. | 2 |
Showing 12 of 33. All products under Bag, Urine Collection, Leg, For External Use, Non-Sterile
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.