Premier
1-Piece Urostomy Pouch, Soft Convex, CeraPlus
27manufacturers in China registered for this device type
87catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (9), Jiangsu (6), Shanghai (4). 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 |
| Ningbo Great Mountain Medical Instruments Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 12 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| Shanghai Jolly Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 99 |
| Shanghai Lions Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 82 |
| Shanghai NEO-Medical Import & Export Co., Ltd. | Shanghai | Shanghai | Exporter | 59 |
| Ningbo Chibanda IMP &EXP Co., Ltd. | Ningbo | Zhejiang | Manufacturer | 59 |
| Jcmed Tianjin Import AND Export Co., Ltd. | Tianjin | Tianjin | Manufacturer | 51 |
| Jiangsu WLD Medical Co., Ltd. | Yizheng | Jiangsu | Contract manufacturer | 50 |
| Ningbo Risenmed Technology Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 42 |
| Rusun Medical Co., Ltd. | Yichun | Jiangxi | Manufacturer | 37 |
Showing 12 of 27. All 27 manufacturers in China registered for Bag, Urine Collecting, Ureterostomy
Record
| Listed by | Hollister Incorporated, United States |
|---|---|
| FDA product code | EXG |
| Device type | Bag, Urine Collecting, Ureterostomy |
| 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 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, serial number |
| Packaging | Cas of 24 |
| Sizes | Lumen/inner diameter 13 to 64 mm |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 8412 | Lumen/Inner Diameter 19 mm | 5 | In distribution |
| 84295 | Lumen/Inner Diameter 29 mm | 5 | In distribution |
| 84292 | Lumen/Inner Diameter 19 mm | 5 | In distribution |
| 84694 | Lumen/Inner Diameter 51 mm | 10 | In distribution |
| 8497 | Lumen/Inner Diameter 35 mm | 5 | In distribution |
| 8464 | Lumen/Inner Diameter 51 mm | 10 | In distribution |
| 84711 | Lumen/Inner Diameter 51 mm | 5 | In distribution |
| 8449 | Lumen/Inner Diameter 44 mm | 10 | In distribution |
| 84996 | Lumen/Inner Diameter 32 mm | 5 | In distribution |
| 8415 | Lumen/Inner Diameter 29 mm | 5 | In distribution |
| 84499 | Lumen/Inner Diameter 44 mm | 10 | In distribution |
| 8443 | Lumen/Inner Diameter 38 mm | 10 | In distribution |
| 84891 | Lumen/Inner Diameter 16 mm | 5 | In distribution |
| 84293 | Lumen/Inner Diameter 22 mm | 5 | In distribution |
| 84404 | Lumen/Inner Diameter 25 mm | 5 | In distribution |
| 8489 | Lumen/Inner Diameter 44 mm | 5 | In distribution |
| 8499 | Lumen/Inner Diameter 44 mm | 5 | In distribution |
| 84898 | Lumen/Inner Diameter 38 mm | 5 | In distribution |
| 84794 | Lumen/Inner Diameter 25 mm | 5 | In distribution |
| 84997 | Lumen/Inner Diameter 35 mm | 5 | In distribution |
| 84294 | Lumen/Inner Diameter 25 mm | 5 | In distribution |
| 8440 | Lumen/Inner Diameter 64 mm | 10 | In distribution |
| 8493 | Lumen/Inner Diameter 22 mm | 5 | In distribution |
| 84999 | Lumen/Inner Diameter 44 mm | 5 | In distribution |
| 8496 | Lumen/Inner Diameter 32 mm | 5 | In distribution |
| 84892 | Lumen/Inner Diameter 19 mm | 5 | In distribution |
| 8483 | Lumen/Inner Diameter 22 mm | 5 | In distribution |
| 84698 | Lumen/Inner Diameter 32 mm | 10 | In distribution |
| 84692 | Lumen/Inner Diameter 25 mm | 10 | In distribution |
| 8434 | Lumen/Inner Diameter 25 mm | 5 | In distribution |
| 844011 | Lumen/Inner Diameter 51 mm | 5 | In distribution |
| 8474 | Lumen/Inner Diameter 25 mm | 5 | In distribution |
| 84991 | Lumen/Inner Diameter 16 mm | 5 | In distribution |
| 84134 | Lumen/Inner Diameter 25 mm | 5 | In distribution |
| 84699 | Lumen/Inner Diameter 44 mm | 10 | In distribution |
| 84893 | Lumen/Inner Diameter 22 mm | 5 | In distribution |
| 84998 | Lumen/Inner Diameter 38 mm | 5 | In distribution |
| 84494 | Lumen/Inner Diameter 51 mm | 10 | In distribution |
| 8438 | Lumen/Inner Diameter 38 mm | 5 | In distribution |
| 8495 | Lumen/Inner Diameter 29 mm | 5 | In distribution |
| 8485 | Lumen/Inner Diameter 29 mm | 5 | In distribution |
| 84490 | Lumen/Inner Diameter 64 mm | 10 | In distribution |
| 8469 | Lumen/Inner Diameter 44 mm | 10 | In distribution |
| 8479111 | Lumen/Inner Diameter 51 mm | 5 | In distribution |
| 84890 | Lumen/Inner Diameter 13 mm | 5 | In distribution |
| 8488 | Lumen/Inner Diameter 38 mm | 5 | In distribution |
| 8486 | Lumen/Inner Diameter 32 mm | 5 | In distribution |
| 8462 | Lumen/Inner Diameter 25 mm | 10 | In distribution |
| 8413 | Lumen/Inner Diameter 22 mm | 5 | In distribution |
| 8448 | Lumen/Inner Diameter 32 mm | 10 | In distribution |
| 8491 | Lumen/Inner Diameter 16 mm | 5 | In distribution |
| 8482 | Lumen/Inner Diameter 19 mm | 5 | In distribution |
| 84590 | Lumen/Inner Diameter 64 mm | 10 | In distribution |
| 84798 | Lumen/Inner Diameter 38 mm | 5 | In distribution |
| 8463 | Lumen/Inner Diameter 38 mm | 10 | In distribution |
| 84995 | Lumen/Inner Diameter 29 mm | 5 | In distribution |
| 8484 | Lumen/Inner Diameter 25 mm | 5 | In distribution |
| 84497 | Lumen/Inner Diameter 19 mm | 10 | In distribution |
| 84138 | Lumen/Inner Diameter 38 mm | 5 | In distribution |
| 84899 | Lumen/Inner Diameter 44 mm | 5 | In distribution |
| 8447 | Lumen/Inner Diameter 19 mm | 10 | In distribution |
| 84895 | Lumen/Inner Diameter 29 mm | 5 | In distribution |
| 8467 | Lumen/Inner Diameter 19 mm | 10 | In distribution |
| 8450 | Lumen/Inner Diameter 64 mm | 10 | In distribution |
| 8480 | Lumen/Inner Diameter 13 mm | 5 | In distribution |
| 8494 | Lumen/Inner Diameter 25 mm | 5 | In distribution |
| 8414 | Lumen/Inner Diameter 25 mm | 5 | In distribution |
| 8439111 | Lumen/Inner Diameter 51 mm | 5 | In distribution |
| 8498 | Lumen/Inner Diameter 38 mm | 5 | In distribution |
| 84690 | Lumen/Inner Diameter 64 mm | 10 | In distribution |
| 8478 | Lumen/Inner Diameter 38 mm | 5 | In distribution |
| 84894 | Lumen/Inner Diameter 25 mm | 5 | In distribution |
| 8492 | Lumen/Inner Diameter 19 mm | 5 | In distribution |
| 84498 | Lumen/Inner Diameter 32 mm | 10 | In distribution |
| 8442 | Lumen/Inner Diameter 25 mm | 10 | In distribution |
| 84993 | Lumen/Inner Diameter 22 mm | 5 | In distribution |
| 84992 | Lumen/Inner Diameter 19 mm | 5 | In distribution |
| 84896 | Lumen/Inner Diameter 32 mm | 5 | In distribution |
| 8460 | Lumen/Inner Diameter 64 mm | 10 | In distribution |
| 84994 | Lumen/Inner Diameter 25 mm | 5 | In distribution |
| 841311 | Lumen/Inner Diameter 55 mm | 5 | In distribution |
| 84693 | Lumen/Inner Diameter 38 mm | 10 | In distribution |
| 84408 | Lumen/Inner Diameter 38 mm | 5 | In distribution |
| 8481 | Lumen/Inner Diameter 16 mm | 5 | In distribution |
| 84897 | Lumen/Inner Diameter 35 mm | 5 | In distribution |
| 8468 | Lumen/Inner Diameter 32 mm | 10 | In distribution |
| 8487 | Lumen/Inner Diameter 35 mm | 5 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Safe N Simple | Safe N Simple LLC | 30 |
| New Image | Hollister Incorporated | 18 |
| Securi-T | Hollister Incorporated | 11 |
| Emsrun | Wuxi Emsrun Technology Co., Ltd. | 6 |
| Karaya 5 | Hollister Incorporated | 5 |
| Lightning X Products,Inc | Wuxi Emsrun Technology Co., Ltd. | 5 |
| MDK-Medical | Henan Maidingkang Medical Technology Co., Ltd. | 3 |
| Bag, Urine Collecting, Ureterostomy | Henan Maidingkang Medical Technology Co., Ltd. | 2 |
| Pouchkins | Hollister Incorporated | 2 |
| McKesson | Mckesson Medical-Surgical Inc. | 1 |
| SecuriT | Hollister Incorporated | 1 |
| Esteem+ | Convatec, Purchasing Department | 1 |
Showing 12 of 13. All products under Bag, Urine Collecting, Ureterostomy
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.