Coloplast
Coloplast Fistula and Wound Management System / Coloplast / Coloplast Fistula and wound management system / Coloplast Free. without filter. 1 Fistula and Wound Manager Midi. 1 Fistula…
Coloplast Fistula and Wound Management System / Coloplast / Coloplast Fistula and wound management system / Coloplast Free. without filter. 1 Fistula and Wound Manager Midi. 1 Fistula Flexible Lid Midi without filter. 1 Tracing guide. 1 Transparent cover sheet. 1 Fistula Drain Port. 1 Clamp. 1 Pump per retail box. Midi. Fistula and Wound Manager Size Midi.
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 | Coloplast A/S, Denmark |
|---|---|
| FDA product code | FON |
| Device type | Bag, Drainage, With Adhesive, Ostomy |
| Device class | Class 1 |
| Regulation | 21 CFR 876.5900 |
| Establishment | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-03-11 |
| Record revised | 2023-03-13 (version 2) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Storage | Special storage condition: This way up. |
| Packaging | Shipper box of 2, shipper box of 10, retail box of 3, retail box of 6, shipper box of 6 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 14050 | Fistula and Wound Manager Size Mini | In distribution | |
| 14010 | 10 | In distribution | |
| 14021 | Fistula and Wound Manager Size Mini | 10 | In distribution |
| 14070 | Fistula and Wound Manager Size Maxi | In distribution | |
| 14041 | Fistula and Wound Manager Size Maxi | 10 | In distribution |
| 14060 | Fistula and Wound Manager Size Midi | In distribution | |
| 14031 | Fistula and Wound Manager Size Midi | 10 | In distribution |
| 14010 | 6 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Esteem+ | Convatec, Purchasing Department | 92 |
| 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 |
| 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
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.