PureWick
PureWick Flex Female External Catheter is a wick accessory used with the PureWick Urine Collection System. Its external design draws voided urine away from the body toward the collection…
PureWick Flex Female External Catheter is a wick accessory used with the PureWick Urine Collection System. Its external design draws voided urine away from the body toward the collection system as an external collection device.
The Flex version has bendable tubing and a multi-layer wick, distinguishing it from other PureWick catheter variants. The filed kit also lists adhesive components for acute-care use.
Listed Item
PureWick Flex Female External Catheter Kit w/ Adhesive, Acute Care
Wick and Collection System
The external wick sits at the body interface and draws voided urine through tubing to the separate collection system. It is an external collection accessory rather than an internally placed catheter.
PureWick Flex combines a layered wick with bendable tubing. Those features define the Flex configuration and connect the collection interface to the system’s tubing.
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 | C.R. Bard, Inc., United States |
|---|---|
| FDA product code | NZU |
| Device type | Collector, Urine, Powered, Non Indwelling Catheter |
| Device class | Class 1 |
| Regulation | 21 CFR 876.5250 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2024-05-31 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Over the counter | Yes |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Storage | Storage environment temperature 41 to 104 °F; Storage environment humidity 25 to 90 % RH; Storage environment atmospheric pressure 70 to 106 KiloPascal |
| Packaging | Case of 30, box of 6, case of 60, case of 100 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PWMX30 | In distribution | |
| PW300 | In distribution | |
| PW300PC | In distribution | |
| PWKIT03H | In distribution | |
| PW300CASE | In distribution | |
| PWA300H | In distribution | |
| PWF030FX | In distribution | |
| PWFXH30 | In distribution | |
| PWF030KX | In distribution | |
| PWF030KXS | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| Boehringer® CareDry™ Porifem | Boehringer Laboratories, LLC | 1 |
Showing 12 of 36. All products under Collector, Urine, Powered, Non Indwelling Catheter
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.