Cook
Low Pressure 3-way Stopcock Clear Plastic Large Bore
33manufacturers in China registered for this device type
49catalogue numbers in this listing
4recalls on this code
Who Else Makes It
Concentrated in Jiangsu (18), Zhejiang (9), Guangdong (3). 6 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 |
| Principle & Will Biotech (Pinghu) Co., Ltd. | Pinghu | Zhejiang | Contract manufacturer | 39 |
| Ningbo Luke Medical Devices Co., Ltd. | Yuyao | Zhejiang | Contract manufacturer | 27 |
| Conod Medical Shuyang Co., Ltd. | Shuyang | Jiangsu | Contract manufacturer | 22 |
| Changzhou DSB Medical Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 16 |
| Alleva Medical (D.G.) Ltd | Dongguan | Guangdong | Contract manufacturer | 13 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
| Huzhou Junda Industry Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 129 |
| GRI Medical & Electronic Technology Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 71 |
| Sterigenics Shanghai ETO Ltd. | Shanghai | Shanghai | Contract manufacturer | 65 |
| Guangzhou Nuoning Medical Supplies Co., Ltd. | Guangzhou | Guangdong | Contract manufacturer | 62 |
Showing 12 of 33. All 33 manufacturers in China registered for Accessories, Catheter
Record
| Listed by | Cook Incorporated, United States |
|---|---|
| FDA product code | KGZ |
| Device type | Accessories, 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 | 2026-05-18 (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 | 2022-02-25 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| G04472 | In distribution | |
| G02727 | In distribution | |
| G03611 | In distribution | |
| G00966 | In distribution | |
| G07618 | In distribution | |
| G01488 | In distribution | |
| G06299 | In distribution | |
| G00965 | In distribution | |
| G00918 | In distribution | |
| G03440 | In distribution | |
| G02735 | In distribution | |
| G07467 | In distribution | |
| G01343 | In distribution | |
| G00164 | In distribution | |
| G04725 | In distribution | |
| G03879 | In distribution | |
| G00218 | In distribution | |
| G02666 | In distribution | |
| G00077 | In distribution | |
| G00211 | In distribution | |
| G00219 | In distribution | |
| G00212 | In distribution | |
| G55179 | In distribution | |
| G50006 | In distribution | |
| G04480 | In distribution | |
| G04888 | In distribution | |
| G01617 | In distribution | |
| G01320 | In distribution | |
| G03878 | In distribution | |
| G07840 | In distribution | |
| G00076 | In distribution | |
| G00078 | In distribution | |
| G05302 | In distribution | |
| G05609 | In distribution | |
| G05301 | In distribution | |
| G05641 | In distribution | |
| G10501 | In distribution | |
| G03025 | In distribution | |
| G01462 | In distribution | |
| G00220 | In distribution | |
| G01079 | In distribution | |
| G00213 | In distribution | |
| G01203 | In distribution | |
| G03468 | In distribution | |
| G06889 | In distribution | |
| G06802 | In distribution | |
| G06540 | In distribution | |
| G02689 | In distribution | |
| G10502 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| MedDrain | Armm, Inc. | 77 |
| Silicone Drainage Tube | Fortune Medical Instrument Corp. | 74 |
| Typenex Wound Drainage | Typenex Medical, LLC | 56 |
| Marina Medical | Marina Medical Instruments, Inc. | 48 |
| Curaplex | Bound Tree Medical, LLC | 36 |
| Mediplus | Mediplus Ltd. | 29 |
| AlliedSil™ Silicone Tubing | Implantech Associates, Inc. | 24 |
| Arrow | Teleflex Medical LLC | 23 |
| Silicone Thoracic Catheters | Atrium Medical Corporation | 21 |
| Neff | Cook Incorporated | 18 |
| Silhouette | Cook Incorporated | 16 |
| Argyle | Cardinal Health | 16 |
Showing 12 of 111. All products under Accessories, Catheter
Recalls
4 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2019-05-02 | Class II | Under Investigation by firm | The products may have been manufactured without the bottom seal on the outer packaging, compromising the sterility of the product. | 97 | 2019-08-23 |
| 2017-02-01 | Class II | Under Investigation by firm | Devices using a specific hemostatic valve design, referred to as a blue valve or polyisoprene valve, have an increase in reports of blood loss associated with the devices which could result in delay in procedure and blood loss from patients | 1,589 | 2018-09-28 |
| 2016-04-15 | Class II | Unknown/Undetermined by firm | Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. degradation could include loss of device function, separation of a device segment leading to medical intervention, or complications | 5,020 | 2017-08-04 |
| 2016-04-15 | Class II | Unknown/Undetermined by firm | Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. degradation could include loss of device function, separation of a device segment leading to medical intervention, or complications | 148,334 | 2017-08-04 |
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.