Cardinal Health
Cardiothoracic Multi-Port Connector 10mm to 15mm with 3-5mm Drain Ports
15manufacturers in China registered for this device type
9catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (9), Shanghai (3), Zhejiang (3). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Conod Medical Co., Limited | Changshu | Jiangsu | Contract manufacturer | 48 |
| Conod Medical Shuyang Co., Ltd. | Shuyang | Jiangsu | Contract manufacturer | 22 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Zogear Medical Co., Ltd. | Yizheng | Jiangsu | Contract manufacturer | 75 |
| Sterigenics Shanghai ETO Ltd. | Shanghai | Shanghai | Contract manufacturer | 65 |
| Ningbo Chibanda IMP &EXP Co., Ltd. | Ningbo | Zhejiang | Manufacturer | 59 |
| Amsino Medical (Kunshan) Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 53 |
| Steris Sterilization Technologies (Suzhou) Ltd | Suzhou | Jiangsu | Contract manufacturer | 44 |
| Changshu Rozer Sterilization Technology Co., Ltd. | Changshu | Jiangsu | Contract manufacturer | 43 |
| Joykey Industrial (Pinghu) Limited | Pinghu | Zhejiang | Contract manufacturer | 43 |
| Suzhou Shangchuang Technology Service Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 23 |
| Shaoxing Undis Medical Technology Company Limited | Shaoxing | Zhejiang | Manufacturer | 17 |
Showing 12 of 15. All 15 manufacturers in China registered for Connector, Catheter
Record
| Listed by | Cardinal Health 200, LLC, United States |
|---|---|
| FDA product code | GCD |
| Device type | Connector, Catheter |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4200 |
| Establishment | Contract manufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-05-27 |
| Record revised | 2024-10-30 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Ethylene Oxide |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number |
| Packaging | Case of 8, box of 10, case of 6, box of 20 |
| Distribution end date | 2024-10-30 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SU130-1342 | In distribution | |
| SU130-4601 | In distribution | |
| SU130-1315 | In distribution | |
| SU130-1340 | In distribution | |
| SU130-1315 | In distribution | |
| SU130-1342 | Withdrawn | |
| SU130-4601 | Withdrawn | |
| SU130-1340 | Withdrawn | |
| CT-131 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Silicone Penrose Drain Tube | Fortune Medical Instrument Corp. | 38 |
| Pleur-Evac | Teleflex Medical LLC | 26 |
| Silicone Flat Drain | Fortune Medical Instrument Corp. | 14 |
| Silicone Round Drain | Fortune Medical Instrument Corp. | 14 |
| Cook | Cook Incorporated | 14 |
| Silicone Round Drain Kit | Fortune Medical Instrument Corp. | 12 |
| Argyle | Cardinal Health | 10 |
| Silicone Flat Drain Kit | Fortune Medical Instrument Corp. | 8 |
| Argyle | Cardinal Health 200, LLC | 8 |
| Silicone Endo-Drain Kit | Fortune Medical Instrument Corp. | 6 |
| Silicone Vac-Drain | Fortune Medical Instrument Corp. | 6 |
| Silicone Vac-Drain Kit | Fortune Medical Instrument Corp. | 6 |
Showing 12 of 49. All products under Connector, Catheter
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Cardinal Health 200, LLC | UDI-DI | 2024-03-27 | Class II | Under Investigation by firm | Cardinal Health is issuing a lot number specific voluntary removal of Jackson-Pratt 3-Spring Reservoir kits due to specific products being shipped to users before undergoing sterilization. | 64 cases of 6 |
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.