Esteem Synergy
Esteem Synergy® Standard Urostomy Pouch W/Accuseal® Tap, One Sided Comfort Panel/ 2 Accuseal® Adapters/Transparent Medium
4manufacturers in China registered for this device type
8catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (2), Jiangsu (1), Henan (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| Tongxiang BAO-Health Medical Instrument Co., Ltd. | Tongxiang | Zhejiang | Manufacturer | 10 |
| Henan Maidingkang Medical Technology Co., Ltd. | Changyuan | Henan | Repacker / relabeller | 7 |
Record
| Listed by | Convatec, Purchasing Department |
|---|---|
| FDA product code | EXH |
| Device type | Bag, Urinary, Ileostomy |
| Device class | Class 1 |
| Regulation | 21 CFR 876.5900 |
| Premarket notification | Exempt |
| Record published | 2019-04-19 |
| Record revised | 2025-04-01 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 24 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 405450 | 10 | In distribution | |
| 405452 | 10 | In distribution | |
| 405448 | 10 | In distribution | |
| 405446 | 10 | In distribution | |
| 405453 | 10 | In distribution | |
| 405449 | 10 | In distribution | |
| 405447 | 10 | In distribution | |
| 405451 | 10 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Esteem | Convatec, Purchasing Department | 31 |
| Activelife | Convatec, Purchasing Department | 25 |
| SUR-FIT Natura | Convatec, Purchasing Department | 23 |
| MDK-Medical | Henan Maidingkang Medical Technology Co., Ltd. | 10 |
| Natura+ | Convatec, Purchasing Department | 5 |
| Bag, Urinary, Ileostomy | Henan Maidingkang Medical Technology Co., Ltd. | 2 |
| Accuseal | Convatec, Purchasing Department | 2 |
| Active Life | Convatec, Purchasing Department | 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.