Streamline External Urine Management Device
Catalogue number 700-120, listed by Sage Products LLC, United States, under Collector, Urine, Powered, Non Indwelling Catheter. 13 manufacturers in China are registered for this product code.
Who Else Makes It
Concentrated in Guangdong (7), Zhejiang (2), Hong Kong (2). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Haiyan Kangyuan Medical Instrument Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 17 |
| Shenzhen HYS Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 6 |
| Enpro Trading (Hong Kong) Limited | Wan Chai Wan Chai | Hong Kong | Contract manufacturer | 1 |
| Ningbo Chibanda IMP &EXP Co., Ltd. | Ningbo | Zhejiang | Manufacturer | 59 |
| Mobility Source Medical Technology Co., Ltd. | Foshan | Guangdong | Contract manufacturer | 26 |
| Guangdong Shunde LQX Health Technology Inc. | Foshan | Guangdong | Contract manufacturer | 24 |
| K-MED Co., Ltd. | Yangzhou | Jiangsu | Manufacturer | 20 |
| Foshan Maikang Medical Equipment Co., Ltd. | Foshan | Guangdong | Manufacturer | 9 |
| Qingdao Traworks Co., Ltd. | Qingdao | Shandong | Exporter | 7 |
| Foshan Haiseer Electronic Technology Co., Ltd. | Foshan | Guangdong | Manufacturer | 6 |
| Shenzhen Kesite Digital Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 4 |
| Foshan King Wonder HI-Tech Co., Ltd. | Foshan | Guangdong | Contract manufacturer | 2 |
Showing 12 of 13. All 13 manufacturers in China registered for Collector, Urine, Powered, Non Indwelling Catheter
Record
| Listed by | Sage Products LLC, United States |
|---|---|
| FDA product code | NZU |
| Device type | Collector, Urine, Powered, Non Indwelling Catheter |
| Device class | Class 1 |
| Regulation | 21 CFR 876.5250 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-05-24 |
| Record revised | 2024-01-15 (version 3) |
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 |
| Packaging | Case of 40 |
| Distribution end date | 2022-07-05 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 700-120 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| PureWick | C.R. Bard, Inc. | 10 |
| PureWick Female External Catheter | C.R. Bard, Inc. | 5 |
| PureWick Urine Collection System | C.R. Bard, Inc. | 3 |
| Boehringer® CareDry™ System | Boehringer Laboratories, LLC | 2 |
| UriCap Base kit box of 30 | Tilla Care Ltd | 2 |
| Extension Tube SX | Tilla Care Ltd | 1 |
| UriCap Female Device | Tilla Care Ltd | 1 |
| Tube Connector | Tilla Care Ltd | 1 |
| PureWick Male | C.R. Bard, Inc. | 1 |
| Home Sample Kits (box of 5) | Tilla Care Ltd | 1 |
| Surity Carbon Filters | Wellspect Healthcare | 1 |
| UriCap Female Starter kit | Tilla Care Ltd | 1 |
Showing 12 of 36. All products under Collector, Urine, Powered, Non Indwelling Catheter
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|
| 2023-10-23 | Class II | Process change control | A small percentage of devices in three lots of product may contain a tape with a natural rubber latex adhesive which is not declared on the label | 174,960 devices |
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.