Cook
Pericardiocentesis Pig-Lock Drainage Catheter - Polyurethane
24manufacturers in China registered for this device type
85catalogue numbers in this listing
2recalls on this code
Who Else Makes It
Concentrated in Jiangsu (7), Zhejiang (7), Guangdong (5). 5 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 |
| Ningbo Luke Medical Devices Co., Ltd. | Yuyao | Zhejiang | Contract manufacturer | 27 |
| Modern Medical Equipment Manufacturing Ltd. | Heng Li, Dongguan | Guangdong | Contract manufacturer | 26 |
| Zhejiang Baite Medical Appliances Co., Ltd. | Huzhou | Zhejiang | Contract manufacturer | 13 |
| Medwell Technology Limited | Dongguan | Guangdong | Contract manufacturer | 10 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Huzhou Junda Industry Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 129 |
| Zhejiang Lidesen Medical Instrument Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 100 |
| Sterigenics Shanghai ETO Ltd. | Shanghai | Shanghai | Contract manufacturer | 65 |
Showing 12 of 24. All 24 manufacturers in China registered for Catheter, Irrigation
Record
| Listed by | Cook Incorporated, United States |
|---|---|
| FDA product code | GBX |
| Device type | Catheter, Irrigation |
| 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 | 2025-12-15 (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. |
| Distribution end date | 2022-02-02 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| G06362 | In distribution | |
| G08454 | In distribution | |
| G10213 | In distribution | |
| G06363 | In distribution | |
| G03559 | In distribution | |
| G06357 | In distribution | |
| G06366 | In distribution | |
| G05464 | In distribution | |
| G06356 | In distribution | |
| G06372 | In distribution | |
| G07270 | In distribution | |
| G07259 | In distribution | |
| G05463 | In distribution | |
| G06336 | In distribution | |
| G06338 | In distribution | |
| G06343 | In distribution | |
| G06341 | In distribution | |
| G05462 | In distribution | |
| G06787 | In distribution | |
| G07090 | In distribution | |
| G06358 | In distribution | |
| G04228 | In distribution | |
| G04220 | In distribution | |
| G06360 | In distribution | |
| G04891 | In distribution | |
| G10212 | In distribution | |
| G06345 | In distribution | |
| G05461 | In distribution | |
| G43558 | In distribution | |
| G06370 | In distribution | |
| G06786 | In distribution | |
| G06335 | In distribution | |
| G55719 | In distribution | |
| G07241 | In distribution | |
| G55720 | In distribution | |
| G55718 | In distribution | |
| G04137 | In distribution | |
| G05457 | In distribution | |
| G55717 | In distribution | |
| G07244 | In distribution | |
| G07242 | In distribution | |
| G06791 | In distribution | |
| G05777 | In distribution | |
| G05453 | In distribution | |
| G05161 | In distribution | |
| G04139 | In distribution | |
| G53746 | In distribution | |
| G06348 | In distribution | |
| G08456 | In distribution | |
| G28275 | In distribution | |
| G08455 | In distribution | |
| G06368 | In distribution | |
| G06361 | In distribution | |
| G10211 | In distribution | |
| G04507 | In distribution | |
| G05455 | In distribution | |
| G06367 | In distribution | |
| G06352 | In distribution | |
| G07243 | In distribution | |
| G06359 | In distribution | |
| G06339 | In distribution | |
| G06340 | In distribution | |
| G10214 | In distribution | |
| G06355 | In distribution | |
| G06885 | In distribution | |
| G05454 | In distribution | |
| G10215 | In distribution | |
| G10210 | In distribution | |
| G06354 | In distribution | |
| G06365 | In distribution | |
| G06364 | In distribution | |
| G04226 | In distribution | |
| G06346 | In distribution | |
| G06369 | In distribution | |
| G03125 | In distribution | |
| G02433 | In distribution | |
| G04251 | In distribution | |
| G07091 | In distribution | |
| G10643 | Withdrawn | |
| G03282 | Withdrawn | |
| G48638 | Withdrawn | |
| G08289 | Withdrawn | |
| G05251 | Withdrawn | |
| G03286 | Withdrawn | |
| G05252 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| One-Step™ | Merit Medical Systems, Inc. | 167 |
| Cardinal Health | Cardinal Health 200, LLC | 109 |
| ReSolve® | Merit Medical Systems, Inc. | 68 |
| Pleur-Evac | Teleflex Medical LLC | 66 |
| Jackson-Pratt | Cardinal Health 200, LLC | 47 |
| Total Abscession | AngioDynamics, Inc. | 36 |
| Channel Drain | C.R. Bard, Inc. | 36 |
| ReSolve Mini™ | Merit Medical Systems, Inc. | 32 |
| Silicone Tubing, Radiopaque | Bentec Medical OpCo, LLC. | 25 |
| Blake | Ethicon, Inc. | 19 |
| Silicone Tubing, Translucent | Bentec Medical OpCo, LLC. | 19 |
| Thoracentesis and Paracentesis Set | Merit Medical Systems, Inc. | 17 |
Showing 12 of 223. All products under Catheter, Irrigation
Recalls Naming This Product
2 recalls name this product by its own identifiers, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Cook Incorporated | UDI-DI | 2026-03-05 | Class II | Incorrect or no expiration date | Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. | 2 units | |
| Cook Incorporated | UDI-DI | 2020-03-06 | Class II | Under Investigation by firm | The printed expiration dates are incorrect. | 25 | 2020-12-18 |
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.