Rusch
RUSCH Medium Leg bag with Easy-Tap & PVC Extension Tubing
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 | Teleflex Medical LLC, 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 | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2019-06-20 |
| Record revised | 2024-01-11 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Box of 48, box of 24 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| IPN054584 | In distribution | |
| IPN054586 | In distribution | |
| IPN054585 | In distribution | |
| IPN054583 | 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 |
| Vive | Vive Health LLC | 4 |
| AMSure® Urinary Leg Bag with Extension Tube | Amsino Medical Inc. | 4 |
| Neil Medical Group | Neil Medical Group | 4 |
Showing 12 of 46. All products under Bag, Urine Collection, Leg, For External Use, Sterile
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2011-06-02 | Not classified | Other | Sterile integrity cannot be guaranteed. | 14,488 eaches | 2013-04-05 |
| 2011-06-02 | Not classified | Other | Sterile integrity cannot be guaranteed. | see line 1. | 2013-04-05 |
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.