Hollister
Wound Drainage Collector with Barrier
7manufacturers in China registered for this device type
9catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (4), Jiangsu (2), Shandong (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 |
|---|---|---|---|---|
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
| Nanjing Anjian Medical Device Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 22 |
| Changzhou Major Medical Products Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 31 |
| Shandong Kangli Medical Equipment Technology Co., Ltd. | Zaozhuang | Shandong | Manufacturer | 23 |
| Zhejiang Ailebao Medical Technology Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 11 |
| Tongxiang BAO-Health Medical Instrument Co., Ltd. | Tongxiang | Zhejiang | Manufacturer | 10 |
| Pinghu Sama Medical Packing Co., Ltd. | Pinghu | Zhejiang | Contract manufacturer | 4 |
Record
| Listed by | Hollister Incorporated, United States |
|---|---|
| FDA product code | GDS |
| Device type | Bag, Stomal |
| Device class | Class 1 |
| Regulation | 21 CFR 876.5900 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-09-21 |
| Record revised | 2025-06-03 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Cas of 6, case of 12, case of 16 |
| Sizes | Outer diameter 7.6 to 9.5 cm; width 10 to 10.2 cm; length 20 to 20.4 cm |
| Distribution end date | 2025-05-30 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 9776 | Outer Diameter 9.5 cm | 10 | In distribution |
| 9775 | Outer Diameter 9.5 cm | 10 | In distribution |
| 9775 | Outer Diameter 9.5 cm | 10 | In distribution |
| 9772 | Outer Diameter 7.6 cm | 10 | In distribution |
| 9772 | Outer Diameter 7.6 cm | 10 | In distribution |
| 9778 | Length 20.4 cm | 3 | In distribution |
| 9773 | Outer Diameter 7.6 cm | 10 | In distribution |
| 9777 | Width 10 cm | 3 | Withdrawn |
| 9777 | Width 10 cm | 3 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Halyard | O&M Halyard, Inc. | 3 |
| OstomyGel | DMC Importacao E Exportacao DE Equipamentos Ltda | 1 |
| Stryker Fecal Management System | Sage Products LLC | 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.