Cook
Connecting Tube for Roller Pump
15manufacturers in China registered for this device type
14catalogue numbers in this listing
1recall
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 | Cook Incorporated, United States |
|---|---|
| FDA product code | GCD |
| Device type | Connector, Catheter |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4200 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2020-10-02 |
| Record revised | 2023-01-20 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Special storage condition: Store in dark, dry, cool place. |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| G27301 | In distribution | |
| G04378 | In distribution | |
| G02791 | In distribution | |
| G49203 | In distribution | |
| G03173 | In distribution | |
| G16562 | In distribution | |
| G02327 | In distribution | |
| G02728 | In distribution | |
| G07643 | In distribution | |
| G02278 | In distribution | |
| G16264 | In distribution | |
| G04711 | In distribution | |
| G02898 | In distribution | |
| G02464 | In distribution |
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 |
| Silicone Round Drain Kit | Fortune Medical Instrument Corp. | 12 |
| Argyle | Cardinal Health | 10 |
| Cardinal Health | Cardinal Health 200, LLC | 9 |
| 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 |
|---|---|---|---|---|---|---|
| Cook Incorporated | UDI-DI | 2022-08-16 | Class II | Under Investigation by firm | Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised. | 240 US; 108 OUS |
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.