Hollister
1-Piece High Output Drainable Ostomy Pouch, Soft Convex, Flextend
18manufacturers in China registered for this device type
16catalogue numbers in this listing
14510(k) clearances naming this product code
Who Else Makes It
Concentrated in Jiangsu (7), Zhejiang (4), Shanghai (3). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Nanjing Anjian Medical Device Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 22 |
| Shaoxing Haoshide Medical Products Co., Ltd. | Shaoxing | Zhejiang | Contract manufacturer | 7 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
| Shanghai Jolly Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 99 |
| Shanghai Lions Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 82 |
| Jiangsu WLD Medical Co., Ltd. | Yizheng | Jiangsu | Contract manufacturer | 50 |
| Changshu Rozer Sterilization Technology Co., Ltd. | Changshu | Jiangsu | Contract manufacturer | 43 |
| Rozer Sterilization Technology Shuyang Company Limited | Shuyang | Jiangsu | Contract manufacturer | 33 |
| Dongguan Hong De Medical Plastic Products Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 32 |
| Aimi Health Technology (Guangdong) Co., Ltd. | Dongguan | Guangdong | Manufacturer | 21 |
| Wenzhou Zuoyou Medical Technoloyg Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 21 |
Showing 12 of 18. All 18 manufacturers in China registered for Collector, Ostomy
Record
| Listed by | Hollister Incorporated, United States |
|---|---|
| FDA product code | EXB |
| Device type | Collector, Ostomy |
| 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 | 2022-11-02 (version 4) |
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 |
| Packaging | Cas of 24, cas of 12, cas of 10, cas |
| Sizes | Lumen/inner diameter 25 to 76 mm; length 25 to 30 cm; total volume 2000 ml |
| Distribution end date | 2025-05-30 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 1796 | Lumen/Inner Diameter 50 mm | 30 | In distribution |
| 83038 | Lumen/Inner Diameter 38 mm | 5 | In distribution |
| 26064 | Lumen/Inner Diameter 64 mm | 10 | In distribution |
| 8770 | 20 | In distribution | |
| 5551 | Total Volume 2000 ml | 10 | In distribution |
| 7331 | 10 | In distribution | |
| 9823 | Length 25 cm | 10 | In distribution |
| 9821 | Length 30 cm | 10 | In distribution |
| 9880 | Length 30 cm | 10 | In distribution |
| 83055 | Lumen/Inner Diameter 55 mm | 5 | In distribution |
| 83025 | Lumen/Inner Diameter 25 mm | 5 | In distribution |
| 3184 | Lumen/Inner Diameter 51 mm | 30 | In distribution |
| 3186 | Lumen/Inner Diameter 76 mm | 30 | In distribution |
| 9779 | 8 | In distribution | |
| 9822 | Length 25 cm | 10 | In distribution |
| 7766 | 100 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Assura | Coloplast A/S | 252 |
| New Image | Hollister Incorporated | 236 |
| SenSura Mio | Coloplast A/S | 200 |
| Premier | Hollister Incorporated | 182 |
| SenSura Mio Convex | Coloplast A/S | 162 |
| SenSura Mio Convex brand logo | Coloplast A/S | 82 |
| SenSura Click | Coloplast A/S | 69 |
| Securi-T | Hollister Incorporated | 59 |
| SenSura Mio Convex Flip | Coloplast A/S | 58 |
| SenSura | Coloplast A/S | 53 |
| Karaya 5 | Hollister Incorporated | 38 |
| Sensura Flex | Coloplast A/S | 37 |
Showing 12 of 31. All products under Collector, Ostomy
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K821680 | 1982-06-24 |
| K813270 | 1981-12-14 |
| K813269 | 1981-12-03 |
| K810807 | 1981-04-07 |
| K810710 | 1981-04-07 |
| K810709 | 1981-04-07 |
| K801503 | 1980-08-13 |
| K791525 | 1979-10-26 |
| K791526 | 1979-10-26 |
| K791535 | 1979-10-26 |
| K791534 | 1979-10-09 |
| K781373 | 1978-09-20 |
| K770439 | 1977-04-15 |
| K770178 | 1977-02-01 |
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.