New Image
Colostomy/Illeostomy Kit, CeraPlus, Soft Convex, Drainable
3manufacturers in China registered for this device type
44catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (2), Jiangsu (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Zhende Medical Co., Ltd. | Shaoxing | Zhejiang | Contract manufacturer | 14 |
| Shaoxing Haoshide Medical Products Co., Ltd. | Shaoxing | Zhejiang | Contract manufacturer | 7 |
| Suzhou Kangyouwei Medical Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 3 |
Record
| Listed by | Hollister Incorporated, United States |
|---|---|
| FDA product code | PQE |
| Device type | Ostomy Care Kit |
| Device class | Class 1 |
| Regulation | 21 CFR 876.5900 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-12-01 |
| Record revised | 2026-07-27 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Cas of 12, cas of 6, case of 12 |
| Sizes | Lumen/inner diameter 32 to 102 mm |
| Distribution end date | 2026-07-25 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 19602 | Lumen/Inner Diameter 44 mm | 5 | In distribution |
| 19303 | Lumen/Inner Diameter 57 mm | 5 | In distribution |
| 19903 | Lumen/Inner Diameter 44 mm | 5 | In distribution |
| 19156 | Lumen/Inner Diameter 89 mm | 5 | In distribution |
| 19003 | Lumen/Inner Diameter 57 mm | 5 | In distribution |
| 19052 | Lumen/Inner Diameter 32 mm | 5 | In distribution |
| 19153 | Lumen/Inner Diameter 57 mm | 5 | In distribution |
| 19904 | Lumen/Inner Diameter 70 mm | 5 | In distribution |
| 19803 | Lumen/Inner Diameter 44 mm | 5 | In distribution |
| 19612 | Lumen/Inner Diameter 44 mm | 5 | In distribution |
| 19902 | Lumen/Inner Diameter 44 mm | 5 | In distribution |
| 19154 | Lumen/Inner Diameter 70 mm | 5 | In distribution |
| 19204 | Lumen/Inner Diameter 70 mm | 5 | In distribution |
| 19103 | Lumen/Inner Diameter 57 mm | 5 | In distribution |
| 19004 | Lumen/Inner Diameter 57 mm | 5 | In distribution |
| 19913 | Lumen/Inner Diameter 57 mm | 5 | In distribution |
| 19203 | Lumen/Inner Diameter 57 mm | 5 | In distribution |
| 19802 | Lumen/Inner Diameter 32 mm | 5 | In distribution |
| 19104 | Lumen/Inner Diameter 70 mm | 5 | In distribution |
| 19254 | Lumen/Inner Diameter 57 mm | 5 | In distribution |
| 19604 | Lumen/Inner Diameter 70 mm | 5 | In distribution |
| 19603 | Lumen/Inner Diameter 57 mm | 5 | In distribution |
| 19304 | Lumen/Inner Diameter 70 mm | 5 | In distribution |
| 19252 | Lumen/Inner Diameter 44 mm | 5 | In distribution |
| 19253 | Lumen/Inner Diameter 44 mm | 5 | In distribution |
| 19106 | Lumen/Inner Diameter 89 mm | 5 | In distribution |
| 19613 | Lumen/Inner Diameter 57 mm | 5 | In distribution |
| 19054 | Lumen/Inner Diameter 57 mm | 5 | In distribution |
| 19403 | Lumen/Inner Diameter 44 mm | 5 | In distribution |
| 19102 | Lumen/Inner Diameter 32 mm | 5 | In distribution |
| 19402 | Lumen/Inner Diameter 32 mm | 5 | In distribution |
| 19053 | Lumen/Inner Diameter 44 mm | 5 | In distribution |
| 19614 | Lumen/Inner Diameter 70 mm | 5 | In distribution |
| 19354 | Lumen/Inner Diameter 70 mm | 5 | In distribution |
| 19914 | Lumen/Inner Diameter 70 mm | 5 | In distribution |
| 19804 | Lumen/Inner Diameter 70 mm | 5 | In distribution |
| 19152 | Lumen/Inner Diameter 44 mm | 5 | In distribution |
| 19002 | Lumen/Inner Diameter 44 mm | 5 | In distribution |
| 19202 | Lumen/Inner Diameter 44 mm | 5 | In distribution |
| 19056 | Lumen/Inner Diameter 102 mm | 5 | In distribution |
| 19006 | Lumen/Inner Diameter 102 mm | 5 | In distribution |
| 19912 | Lumen/Inner Diameter 44 mm | 5 | In distribution |
| 19503 | Lumen/Inner Diameter 57 mm | 5 | Withdrawn |
| 19353 | Lumen/Inner Diameter 57 mm | 5 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Natura | Convatec, Purchasing Department | 12 |
| CeraPlus | Hollister Incorporated | 11 |
| Bynex | Shaoxing Haoshide Medical Products Co., Ltd. | 10 |
| Hollister | Hollister Incorporated | 6 |
| Premier | Hollister Incorporated | 5 |
| ZD | Zhende Medical Co., Ltd. | 2 |
| Brava | Coloplast A/S | 1 |
| Bynex | Zhende Medical Co., Ltd. | 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.