Esteem
Esteem®+ One-Piece Cut-To-Fit Urostomy Pouch With Durahesive Skin Barrier And Accuseal Tap
4manufacturers in China registered for this device type
31catalogue 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 | 2024-03-20 |
| 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 | Pack of 20, pack of 6, pack of 10 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 423718 | 10 | In distribution | |
| 421625 | 10 | In distribution | |
| 422564 | 10 | In distribution | |
| 423704 | 10 | In distribution | |
| 421629 | 10 | In distribution | |
| 422551 | 10 | In distribution | |
| 422558 | 10 | In distribution | |
| 423726 | 10 | In distribution | |
| 422565 | 10 | In distribution | |
| 421626 | 10 | In distribution | |
| 422562 | 10 | In distribution | |
| 421624 | 10 | In distribution | |
| 423705 | 10 | In distribution | |
| 423715 | 10 | In distribution | |
| 423722 | 10 | In distribution | |
| 422560 | 10 | In distribution | |
| 421627 | 10 | In distribution | |
| 423723 | 10 | In distribution | |
| 423717 | 10 | In distribution | |
| 423714 | 10 | In distribution | |
| 422559 | 10 | In distribution | |
| 423727 | 10 | In distribution | |
| 423713 | 10 | In distribution | |
| 423716 | 10 | In distribution | |
| 423712 | 10 | In distribution | |
| 422557 | 10 | In distribution | |
| 422552 | 10 | In distribution | |
| 421631 | 10 | In distribution | |
| 423725 | 10 | In distribution | |
| 421628 | 10 | In distribution | |
| 422553 | 10 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Activelife | Convatec, Purchasing Department | 25 |
| SUR-FIT Natura | Convatec, Purchasing Department | 23 |
| MDK-Medical | Henan Maidingkang Medical Technology Co., Ltd. | 10 |
| Esteem Synergy | Convatec, Purchasing Department | 8 |
| 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 |
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Convatec Limited | UDI-DI | 2026-07-06 | Class II | Material/Component Contamination | Urostomy Pouches may leak from cap during use. | 617850 units |
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.