Dover
Urine Leg Bag with Extension Tube
52manufacturers in China registered for this device type
3catalogue numbers in this listing
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 | Cardinal Health, 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, Reprocessor, Contract steriliser, Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2018-06-29 |
| Record revised | 2023-07-03 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: ; |
| Packaging | Case of 50 |
| Sizes | Length 12 in |
| Distribution end date | 2023-07-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 145516 | Withdrawn | |
| 3433 | Length 12 in | Withdrawn |
| 145514 | Withdrawn |
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.