Uro-Safe® Disposable Vinyl Leg Bag 32 Oz. (1,000 Ml.)
BAG, URINE COLLECTION, LEG, DISPOSABLE, VINYL, STRAPS, THUMB CLAMP 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, THUMB CLAMP 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 defect through each phase of manufacturing and packaged individually in a sterile, easy, peel-open pouch with two(2) “latex-free” leg straps. Features/Contains: Latex-Free, DEHP-Free, Anti-Reflux Valve Chamber, Clear Front with White Back for easy monitoring for blood or other substances in urine, “Latex-Free” Leg Straps with Buttons #60062 and Illustrated Application Instructions.
Who Else Makes It
Concentrated in Jiangsu (18), Zhejiang (16), Shanghai (7). 13 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
| Ningbo Castle Medical Import & Export Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 67 |
| Shanghai Joy Crown Industry Co., Ltd. | Pu Dong New Area | Shanghai | Contract manufacturer | 64 |
| Amsino Medical (Kunshan) Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 53 |
| Conod Medical Co., Limited | Changshu | Jiangsu | Contract manufacturer | 48 |
| Flexicare Medical (Dongguan) Ltd. | Dongguan | Guangdong | Contract manufacturer | 48 |
| Dongguan Hong De Medical Plastic Products Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 32 |
| Conod Medical Shuyang Co., Ltd. | Shuyang | Jiangsu | Contract manufacturer | 22 |
| Tylenol Medical Instruments Co., Ltd. | Zhongshan | Guangdong | Contract manufacturer | 15 |
| Hangzhou Jincheng Medical Supplies Manufacture Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 15 |
| Clinisupplies (Nanjing) Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 13 |
| Primecare Medical (Huzhou) Co., Ltd. | Hu Zhou | Zhejiang | Contract manufacturer | 9 |
Showing 12 of 52. All 52 manufacturers in China registered for Bag, Urine Collection, Leg, For External Use, Sterile
Record
| Listed by | Urocare Products, Inc., United States |
|---|---|
| FDA product code | FAQ |
| Device type | Bag, Urine Collection, Leg, For External Use, Sterile |
| Device class | Class 1 |
| Regulation | 21 CFR 876.5250 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-04-10 |
| Record revised | 2021-04-07 (version 7) |
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 168, case of 12 |
| Sizes | Total volume 1000 ml; depth 0.5 in; height 15 to 16.5 in; weight 0.14 to 0.15 lb; total volume 32 Fluid Ounce; width 5.25 in |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 76320 | Total Volume 1000 ml | In distribution |
| 77321 | Total Volume 32 Fluid Ounce | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Leg Bag | C.R. Bard, Inc. | 20 |
| Flexicare | Flexicare Medical Ltd. | 10 |
| Cardinal Health | Cardinal Health 200, LLC | 8 |
| Exact Medical Manufacturing, Inc. | Exact Medical Manufacturing, Inc. | 7 |
| AMSure® Urinary Leg Bag | Amsino Medical Inc. | 7 |
| MediChoice | Owens & Minor Distribution, Inc. | 5 |
| Rollmed | Hangzhou Rollmed Co., Ltd. | 5 |
| Conveen Security+ | Coloplast A/S | 5 |
| U-Bag Urine Collector | Aspen Surgical Products, Inc. | 5 |
| Rusch | Teleflex Medical LLC | 4 |
| Vive | Vive Health LLC | 4 |
| AMSure® Urinary Leg Bag with Extension Tube | Amsino Medical Inc. | 4 |
Showing 12 of 46. All products under Bag, Urine Collection, Leg, For External Use, 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.