Premier
Colostomy/Ileostomy Kit, SoftFlex
3manufacturers in China registered for this device type
5catalogue 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 |
|---|---|
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date |
| Packaging | Cas of 12 |
| Sizes | Lumen/inner diameter 64 mm |
| Distribution end date | 2026-07-25 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 89002 | Lumen/Inner Diameter 64 mm | 5 | In distribution |
| 89004 | Lumen/Inner Diameter 64 mm | 5 | In distribution |
| 89001 | Lumen/Inner Diameter 64 mm | 5 | Withdrawn |
| 89003 | Lumen/Inner Diameter 64 mm | 5 | Withdrawn |
| 89005 | Lumen/Inner Diameter 64 mm | 5 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| New Image | Hollister Incorporated | 44 |
| Natura | Convatec, Purchasing Department | 12 |
| CeraPlus | Hollister Incorporated | 11 |
| Bynex | Shaoxing Haoshide Medical Products Co., Ltd. | 10 |
| Hollister | Hollister Incorporated | 6 |
| 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.