Fecal Containment Device
FCD Fecal Containment Device
18manufacturers in China registered for this device type
1catalogue number
6510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (7), Zhejiang (4), Shanghai (3). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Nanjing Anjian Medical Device Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 22 |
| Shaoxing Haoshide Medical Products Co., Ltd. | Shaoxing | Zhejiang | Contract manufacturer | 7 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
| Shanghai Jolly Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 99 |
| Shanghai Lions Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 82 |
| Jiangsu WLD Medical Co., Ltd. | Yizheng | Jiangsu | Contract manufacturer | 50 |
| Changshu Rozer Sterilization Technology Co., Ltd. | Changshu | Jiangsu | Contract manufacturer | 43 |
| Rozer Sterilization Technology Shuyang Company Limited | Shuyang | Jiangsu | Contract manufacturer | 33 |
| Dongguan Hong De Medical Plastic Products Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 32 |
| Aimi Health Technology (Guangdong) Co., Ltd. | Dongguan | Guangdong | Manufacturer | 21 |
| Wenzhou Zuoyou Medical Technoloyg Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 21 |
Showing 12 of 18. All 18 manufacturers in China registered for Collector, Ostomy
Record
| Listed by | C.R. Bard, Inc., United States |
|---|---|
| FDA product code | EXB |
| Device type | Collector, Ostomy |
| Device class | Class 1 |
| Regulation | 21 CFR 876.5900 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2020-09-22 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 25 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 190011 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Assura | Coloplast A/S | 252 |
| New Image | Hollister Incorporated | 236 |
| SenSura Mio | Coloplast A/S | 200 |
| Premier | Hollister Incorporated | 182 |
| SenSura Mio Convex | Coloplast A/S | 162 |
| SenSura Mio Convex brand logo | Coloplast A/S | 82 |
| SenSura Click | Coloplast A/S | 69 |
| Securi-T | Hollister Incorporated | 59 |
| SenSura Mio Convex Flip | Coloplast A/S | 58 |
| SenSura | Coloplast A/S | 53 |
| Karaya 5 | Hollister Incorporated | 38 |
| Sensura Flex | Coloplast A/S | 37 |
Showing 12 of 31. All products under Collector, Ostomy
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K862631 | 1986-10-16 |
| K851398 | 1985-05-23 |
| K834575 | 1984-02-04 |
| K821271 | 1982-07-02 |
| K791581 | 1979-10-02 |
| K771775 | 1977-09-30 |
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.