Cook
Connecting Tube Female to Male Luer Lock
13manufacturers in China registered for this device type
38catalogue numbers in this listing
6recalls on this code
Who Else Makes It
Concentrated in Jiangsu (3), Beijing (3), Zhejiang (2). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai INT Medical Instruments Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 10 |
| Elite Medtek(Jiangsu) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 9 |
| Tianjin Demax Medical Technology Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 5 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Zhejiang Mediunion Healthcare Group Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 105 |
| Joykey Industrial (Pinghu) Limited | Pinghu | Zhejiang | Contract manufacturer | 43 |
| Sunny Medical Device (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 11 |
| Tianck Medical Co., Ltd. | Huizhou | Guangdong | Manufacturer | 10 |
| Lepu Medical Technology (Beijing) Co., Ltd. | Beijing | Beijing | Manufacturer | 7 |
| Beijing Target Medical Technologies Inc. | Beijing | Beijing | Contract manufacturer | 7 |
| Beijing Demax Medical Technology Co., Ltd. | Beijing | Beijing | Manufacturer | 5 |
| Curatia Medical Limited | Suzhou | Jiangsu | Specification developer | 5 |
Showing 12 of 13. All 13 manufacturers in China registered for Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Record
| Listed by | Cook Incorporated, United States |
|---|---|
| FDA product code | DTL |
| Device type | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass |
| Device class | Class 2 |
| Regulation | 21 CFR 870.4290 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2017-08-22 |
| Record revised | 2021-06-08 (version 6) |
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 | 2020-01-13 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| G00038 | In distribution | |
| G00063 | In distribution | |
| G03003 | In distribution | |
| G00052 | In distribution | |
| G00068 | In distribution | |
| G00037 | In distribution | |
| G00065 | In distribution | |
| G00053 | In distribution | |
| G00882 | In distribution | |
| G00061 | In distribution | |
| G01256 | In distribution | |
| G01552 | In distribution | |
| G00042 | In distribution | |
| G09433 | In distribution | |
| G00035 | In distribution | |
| G03935 | In distribution | |
| G00030 | In distribution | |
| G00045 | In distribution | |
| G00048 | In distribution | |
| G08713 | In distribution | |
| G00041 | In distribution | |
| G00049 | In distribution | |
| G00066 | In distribution | |
| G00058 | In distribution | |
| G00040 | In distribution | |
| G00067 | In distribution | |
| G00060 | In distribution | |
| G09434 | In distribution | |
| G00059 | In distribution | |
| G28956 | In distribution | |
| G00043 | In distribution | |
| G01572 | In distribution | |
| G00033 | In distribution | |
| G00036 | In distribution | |
| G00069 | In distribution | |
| G00039 | In distribution | |
| G09435 | In distribution | |
| G47747 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DeRoyal | Deroyal Industries, Inc. | 171 |
| Namic | Medline Industries, Inc. | 170 |
| Namic | Navilyst Medical, Inc. | 165 |
| Merit® Manifold | Merit Medical Systems, Inc. | 119 |
| Connector | LivaNova USA, Inc. | 70 |
| Medline Industries, Inc. | Medline Industries, Inc. | 62 |
| Demax | Beijing Demax Medical Technology Co., Ltd. | 60 |
| DLP® | Medtronic, Inc. | 51 |
| Marquis® Stopcock | Merit Medical Systems, Inc. | 40 |
| Unbranded | Advance Medical Designs, Inc. | 30 |
| Contrast Line | Argon Medical Devices, Inc. | 25 |
| INT | Shanghai Kindly Medical Instruments Co., Ltd. | 18 |
Showing 12 of 127. All products under Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Recalls
6 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 |
|---|---|---|---|---|---|
| 2018-03-29 | Class II | Equipment maintenance | Cap-adapter assembly of the device may potentially not be adequately tightened, possibly leading to fluid leakage from or air aspiration into the connecting tube. | 6345 | 2019-04-09 |
| 2018-03-29 | Class II | Equipment maintenance | Cap-adapter assembly of the device may potentially not be adequately tightened, possibly leading to fluid leakage from or air aspiration into the connecting tube. | 304 | 2019-04-09 |
| 2018-03-29 | Class II | Equipment maintenance | Cap-adapter assembly of the device may potentially not be adequately tightened, possibly leading to fluid leakage from or air aspiration into the connecting tube. | 220 | 2019-04-09 |
| 2018-03-29 | Class II | Equipment maintenance | Cap-adapter assembly of the device may potentially not be adequately tightened, possibly leading to fluid leakage from or air aspiration into the connecting tube. | 220 | 2019-04-09 |
| 2018-03-29 | Class II | Equipment maintenance | Cap-adapter assembly of the device may potentially not be adequately tightened, possibly leading to fluid leakage from or air aspiration into the connecting tube. | 886 | 2019-04-09 |
| 2018-03-29 | Class II | Equipment maintenance | Cap-adapter assembly of the device may potentially not be adequately tightened, possibly leading to fluid leakage from or air aspiration into the connecting tube. | 554 | 2019-04-09 |
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.