Conveen Contour
Urine collection bag. Sterile. Leg bag. Inlet tube: 18 inch (45 cm). 21 oz.
52manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
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 | Coloplast A/S, Denmark |
|---|---|
| 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, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-03-11 |
| Record revised | 2022-12-07 (version 2) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: Do not use if package is damaged and consult IFU. |
| Packaging | Retail box of 10, shipper box of 6 |
| Sizes | Length 45 cm; total volume 600 ml; length 18 in; total volume 21 Fluid Ounce |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 05171 | Length 45 cm | 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K924406 | 1992-10-30 |
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.