Contrast Line
Contrast Line 60"(152cm) Female/Rotating Adapter Polyurethane, Braided 1200 PSI
13manufacturers in China registered for this device type
25catalogue numbers in this listing
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 | Argon Medical Devices, Inc., 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, Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K963749 |
| Record published | 2016-09-09 |
| Record revised | 2026-05-11 (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 |
| Packaging | Box of 25 |
| Distribution end date | 2024-12-09 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 193381 | 96″(244cm) Male/Female Polyurethane, Braided 1200 PSI Line | In distribution |
| 193356 | 30″(75cm), 1200 PSI | In distribution |
| 193363 | 20″(50cm) Female/Rotating Adapter (Braided) 1200 PSI Line | In distribution |
| 193375 | 60″(152cm) Female/Rotating Adapter Polyurethane, Braided 1200 PSI | In distribution |
| 193365 | 48″(122cm) Female/Rotating Adapter (Braided) 1200 PSI Line | In distribution |
| 193378 | 72″(183cm) Female/Rotating Adapter Polyurethane, Braided 1200 PSI Line | In distribution |
| 193361 | 48″(122cm) M/F (Braided) 1200 PSI Line | In distribution |
| 193359 | 20″(50cm), 1200 PSI | In distribution |
| 193377 | 72″(183cm) Male/Female Polyurethane, Braided 1200 PSI | In distribution |
| 193353 | 48″(122cm) Male/Female PVC 1200 PSI Line | In distribution |
| 193382 | 96″(244cm) Female/Rotating Adapter Polyurethane, Braided 1200 PSI Line | In distribution |
| 193364 | 30″(75cm) Female/Rotating Adapter (Braided) 1200 PSI Line | In distribution |
| 193362 | 10″(25cm) Female/Rotating Adapter (Braided) 1200 PSI Line | In distribution |
| 193358 | 10″(25cm) M/F (Braided) 1200 PSI Line | In distribution |
| 193351 | 20″(50cm), 1200 PSI | Withdrawn |
| 193368 | 60″(152cm) Female/Rotating Adapter (PVC) 1200 PSI Line | Withdrawn |
| 193373 | 72″(183cm) Female/Rotating Adapter (PVC) 1200 PSI Line | Withdrawn |
| 193352 | 30″(75cm), 1200 PSI | Withdrawn |
| 193355 | 20″(50cm) Female/Rotating Adapter PVC 1200 PSI Line | Withdrawn |
| 193357 | 48″(122cm),1200 PSI | Withdrawn |
| 193360 | 30″(75cm), 1200 PSI | Withdrawn |
| 193350 | 10″(25cm) Male/Female PVC 1200 PSI line | Withdrawn |
| 193366 | 72″(183cm) Male/Female PVC 1200 PSI Line | Withdrawn |
| 193376 | 60″(152cm) Male/Female Polyurethane, Braided 1200 PSI | Withdrawn |
| 193354 | 10″(25cm) Female/Rotating Adapter PVC 1200 PSI Line | 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 |
| Cook | Cook Incorporated | 38 |
| Unbranded | Advance Medical Designs, Inc. | 30 |
| INT | Shanghai Kindly Medical Instruments Co., Ltd. | 18 |
Showing 12 of 127. All products under Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
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.