Uro-Safe® Disposable Vinyl Leg Bag 32 Oz. (1,000 Ml.)
BAG, URINE COLLECTION, LEG, DISPOSABLE, VINYL, STRAPS, TWIST TYPE DRAIN VALVE, LARGE, 32 FL. OZ. (1,000 ML.) Uro-Safe® bags have the first ever, built-in, anti-reflux valve that is…
BAG, URINE COLLECTION, LEG, DISPOSABLE, VINYL, STRAPS, TWIST TYPE DRAIN VALVE, LARGE, 32 FL. OZ. (1,000 ML.) Uro-Safe® bags have the first ever, built-in, anti-reflux valve that is virtually self-cleaning and interference free… ensuring uninterrupted flow and problem free use. Because our anti-reflux valve is enclosed in a hard valve housing, it can’t be held shut even when in sitting or reclining positions like other inferior products. Why settle for anything else? Uro-Safe® vinyl leg bags are for use with Foley® indwelling or male external catheters and urostomy drainage. Each Uro-Safe® bag is hand-tested for defects through each phase of manufacturing and packaged individually in an easy-open Zip-Loc® bag with two(2) “latex-free” leg straps and application instructions. Features/Contains: Latex-Free, DEHP-Free, Anti-Reflux Valve Chamber, Clear Vinyl on Both Sides, “Latex-Free” Leg Straps with Buttons #60062 and Illustrated Application 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 | 2020-07-30 |
| Record revised | 2021-04-07 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Sizes | Total volume 1000 ml; depth 0.5 in; height 15 in; weight 0.14 lb; total volume 32 Fluid Ounce; width 5.25 in |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 78320 | Total Volume 1000 ml | 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.