Active Life
Activelife® Convex One-Piece Pre-Cut Urostomy Pouch With Durahesive® Skin Barrier, Trans Std, 3/4" (19Mm.)
4manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Zhejiang (2), Jiangsu (1), Henan (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| Tongxiang BAO-Health Medical Instrument Co., Ltd. | Tongxiang | Zhejiang | Manufacturer | 10 |
| Henan Maidingkang Medical Technology Co., Ltd. | Changyuan | Henan | Repacker / relabeller | 7 |
Record
| Listed by | Convatec, Purchasing Department |
|---|---|
| FDA product code | EXH |
| Device type | Bag, Urinary, Ileostomy |
| Device class | Class 1 |
| Regulation | 21 CFR 876.5900 |
| Premarket notification | Exempt |
| Record published | 2022-09-28 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 20 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 125363 | 10 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Esteem | Convatec, Purchasing Department | 31 |
| Activelife | Convatec, Purchasing Department | 25 |
| SUR-FIT Natura | Convatec, Purchasing Department | 23 |
| MDK-Medical | Henan Maidingkang Medical Technology Co., Ltd. | 10 |
| Esteem Synergy | Convatec, Purchasing Department | 8 |
| Natura+ | Convatec, Purchasing Department | 5 |
| Bag, Urinary, Ileostomy | Henan Maidingkang Medical Technology Co., Ltd. | 2 |
| Accuseal | Convatec, Purchasing Department | 2 |
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.