Esteem+
Esteem®+ One-Piece Drainable Cut-To-Fit Pouch W/ Invisiclose®, Filter, Modified Stomahesive®, One-Sided Comfort Panel 12" Transparent, 2 2/5" By 2 3/4" (60/70Mm)
49manufacturers in China registered for this device type
92catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (19), Jiangsu (9), Shanghai (7). 5 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 |
| Apex (Guangzhou) Tools & Orthopedics Company | Guangzhou | Guangdong | Contract manufacturer | 62 |
| Henso Medical (Hangzhou) Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 19 |
| Polymed (Xiamen) Plastic Industrial Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 17 |
| Zhejiang TOP-Medical Medical Dressing Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 5 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| Huzhou Junda Industry Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 129 |
| Zhejiang Lidesen Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 100 |
| Anji Spenq Industrial Co., Ltd. | Huzhou | Zhejiang | Manufacturer | 85 |
| Shanghai Joy Crown Industry Co., Ltd. | Pu Dong New Area | Shanghai | Contract manufacturer | 64 |
| Shanghai NEO-Medical Import & Export Co., Ltd. | Shanghai | Shanghai | Exporter | 59 |
Showing 12 of 49. All 49 manufacturers in China registered for Bag, Drainage, With Adhesive, Ostomy
Record
| Listed by | Convatec, Purchasing Department |
|---|---|
| FDA product code | FON |
| Device type | Bag, Drainage, With Adhesive, Ostomy |
| Device class | Class 1 |
| Regulation | 21 CFR 876.5900 |
| Premarket notification | Exempt |
| Record published | 2022-09-29 |
| Record revised | 2025-04-01 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 18, pack of 20, pack of 14, case of 16, pack of 10, case of 14 |
| Distribution end date | 2023-02-26 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 416728 | 10 | In distribution | |
| 423652 | 10 | In distribution | |
| 423644 | 10 | In distribution | |
| 421616 | 10 | In distribution | |
| 422546 | 10 | In distribution | |
| 421848 | 10 | In distribution | |
| 423645 | 10 | In distribution | |
| 416725 | 10 | In distribution | |
| 421622 | 10 | In distribution | |
| 421855 | 10 | In distribution | |
| 422541 | 10 | In distribution | |
| 416748 | 10 | In distribution | |
| 421858 | 10 | In distribution | |
| 421026 | 10 | In distribution | |
| 421617 | 10 | In distribution | |
| 416721 | 10 | In distribution | |
| 421620 | 10 | In distribution | |
| 423646 | 10 | In distribution | |
| 422364 | 10 | In distribution | |
| 416975 | 10 | In distribution | |
| 413519 | 10 | In distribution | |
| 421025 | 10 | In distribution | |
| 423654 | 10 | In distribution | |
| 416751 | 10 | In distribution | |
| 416915 | 5 | In distribution | |
| 421860 | 10 | In distribution | |
| 413518 | 10 | In distribution | |
| 423666 | 10 | In distribution | |
| 423647 | 10 | In distribution | |
| 416732 | 10 | In distribution | |
| 421618 | 10 | In distribution | |
| 416724 | 10 | In distribution | |
| 413522 | 10 | In distribution | |
| 416718 | 10 | In distribution | |
| 416739 | 10 | In distribution | |
| 423659 | 10 | In distribution | |
| 421619 | 10 | In distribution | |
| 416745 | 10 | In distribution | |
| 416749 | 10 | In distribution | |
| 413517 | 10 | In distribution | |
| 421856 | 10 | In distribution | |
| 416750 | 10 | In distribution | |
| 423643 | 10 | In distribution | |
| 422365 | 10 | In distribution | |
| 423653 | 10 | In distribution | |
| 423660 | 10 | In distribution | |
| 416746 | 10 | In distribution | |
| 423656 | 10 | In distribution | |
| 423658 | 10 | In distribution | |
| 422159 | 10 | In distribution | |
| 421857 | 10 | In distribution | |
| 423665 | 10 | In distribution | |
| 416741 | 10 | In distribution | |
| 416742 | 10 | In distribution | |
| 416737 | 10 | In distribution | |
| 421859 | 10 | In distribution | |
| 421853 | 10 | In distribution | |
| 422540 | 10 | In distribution | |
| 422539 | 10 | In distribution | |
| 423651 | 10 | In distribution | |
| 421615 | 10 | In distribution | |
| 416729 | 10 | In distribution | |
| 416743 | 10 | In distribution | |
| 416744 | 10 | In distribution | |
| 423648 | 10 | In distribution | |
| 423664 | 10 | In distribution | |
| 421029 | 10 | In distribution | |
| 413521 | 10 | In distribution | |
| 416733 | 10 | In distribution | |
| 416719 | 10 | In distribution | |
| 413523 | 10 | In distribution | |
| 416908 | 10 | In distribution | |
| 421862 | 10 | In distribution | |
| 416976 | 10 | In distribution | |
| 416740 | 10 | In distribution | |
| 422545 | 10 | In distribution | |
| 416738 | 10 | In distribution | |
| 421861 | 10 | In distribution | |
| 423667 | 10 | In distribution | |
| 413516 | 10 | In distribution | |
| 421027 | 10 | In distribution | |
| 416736 | 10 | In distribution | |
| 413515 | 10 | In distribution | |
| 423657 | 10 | In distribution | |
| 421028 | 10 | In distribution | |
| 422363 | 10 | In distribution | |
| 421854 | 10 | In distribution | |
| 416747 | 10 | In distribution | |
| 421621 | 10 | In distribution | |
| 423661 | 10 | In distribution | |
| 413520 | 10 | In distribution | |
| 416916 | 5 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| SUR-FIT Natura | Convatec, Purchasing Department | 60 |
| Natura | Convatec, Purchasing Department | 39 |
| Activelife | Convatec, Purchasing Department | 39 |
| Eakin | T.G. Eakin, Ltd. | 14 |
| AWI | Apex (Guangzhou) Tools & Orthopedics Company | 14 |
| AWI | Apex (Suzhou) Medical Products Company | 12 |
| Esteem Synergy | Convatec, Purchasing Department | 12 |
| Coloplast | Coloplast A/S | 8 |
| Carbou | Ningbo Kehu Medical Technology Co., Ltd. | 6 |
| ViveCare | Vive Health LLC | 6 |
| Perilav | Stiehl Tech | 5 |
| Osto System | Solomed S.A. DE C.V. | 4 |
Showing 12 of 24. All products under Bag, Drainage, With Adhesive, Ostomy
Recalls Naming This Product
3 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason |
|---|---|---|---|---|---|
| Convatec Limited | UDI-DI | 2026-02-16 | Class II | Process control | Drainable large pouch may leak due to manufacturing issue. |
| Convatec Limited | UDI-DI | 2026-02-16 | Class II | Process control | Drainable large pouch may leak due to manufacturing issue. |
| Convatec Limited | UDI-DI | 2026-02-16 | Class II | Process control | Drainable large pouch may leak due to manufacturing issue. |
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.