Cardinal Health
Irrigation KIT
6manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Jiangsu (5), Guangdong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jiangsu Shenli Medical Production Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 6 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Zogear Medical Co., Ltd. | Yizheng | Jiangsu | Contract manufacturer | 75 |
| Suzhou Texnet | Suzhou | Jiangsu | Contract manufacturer | 47 |
| Dongguan Wanjin Industrial Co., Ltd. | Dongguang | Guangdong | Remanufacturer | 41 |
| Suzhou Acmed Import & Export Co., Ltd. | Suzhou | Jiangsu | Exporter | 27 |
Record
| Listed by | Cardinal Health 200, LLC, United States |
|---|---|
| FDA product code | GBQ |
| Device type | Catheter, Continuous Irrigation |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4200 |
| Establishment | Contract manufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2021-06-07 |
| Record revised | 2022-06-17 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Case of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SBA40IKCTA | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Skater™ Drainage Catheter | Argon Medical Devices, Inc. | 25 |
| Welmed | Welmed, Inc. | 12 |
| Skater™ Single Step Drainage Set | Argon Medical Devices, Inc. | 11 |
| Skater™ All Purpose and Nephrostomy Drainage Set | Argon Medical Devices, Inc. | 8 |
| Skater™ Centesis Catheter | Argon Medical Devices, Inc. | 8 |
| Gesco | Utah Medical Products, Inc. | 2 |
| Perma Pure | Perma Pure, LLC | 1 |
| Coloplast | Coloplast A/S | 1 |
| Drainage Bag | Argon Medical Devices, Inc. | 1 |
| Skater™ Single Step Drainage | Argon Medical Devices, Inc. | 1 |
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.