Leg Bag Holder Extra Large
Catalogue number 00-0038U, listed by Flexicare Medical Ltd., United Kingdom, under System, Urine Drainage, Closed, For Non-Indwelling Catheter, Non-Sterile. 13 manufacturers in China are registered for this product code.
13manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Zhejiang (6), Guangdong (3), Jiangsu (2). 6 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 |
| Flexicare Medical (Dongguan) Ltd. | Dongguan | Guangdong | Contract manufacturer | 48 |
| Changzhou DSB Medical Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 16 |
| Hangzhou Jincheng Medical Supplies Manufacture Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 15 |
| Chengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd. | Chengdu | Sichuan | Contract manufacturer | 10 |
| Integral Medical Products Co., Ltd. | Shaoxing | Zhejiang | Contract manufacturer | 7 |
| Zhejiang Mediunion Healthcare Group Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 105 |
| Shandong Zhushi Pharmaceutical Group Co., Ltd. | Heze | Shandong | Contract manufacturer | 65 |
| Ningbo Risenmed Technology Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 42 |
| K-MED Co., Ltd. | Yangzhou | Jiangsu | Manufacturer | 20 |
| Excellentcare Medical (Huizhou) Ltd. | Huizhou | Guangdong | Manufacturer | 14 |
| Mcreat ( Guangzhou ) BIO-Tech Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 14 |
Showing 12 of 13. All 13 manufacturers in China registered for System, Urine Drainage, Closed, For Non-Indwelling Catheter, Non-Sterile
Record
| Listed by | Flexicare Medical Ltd., United Kingdom |
|---|---|
| FDA product code | NNZ |
| Device type | System, Urine Drainage, Closed, For Non-Indwelling Catheter, Non-Sterile |
| Device class | Class 1 |
| Regulation | 21 CFR 876.5250 |
| Establishment | Contract manufacturer, Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-03-25 |
| Record revised | 2026-05-18 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 00-0038U | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Hollister | Hollister Incorporated | 2 |
| Leg Bag Holder Small | Flexicare Medical Ltd. | 1 |
| Leg Bag Holder Large | Flexicare Medical Ltd. | 1 |
| ASP Medical | ASP Global, LLC | 1 |
| Cure Medical | Convatec, Purchasing Department | 1 |
| Leg Bag Holder Medium | Flexicare Medical Ltd. | 1 |
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.