DeRoyal
Manifold 2 Port Left Hand ONHalf Body High Pressure
13manufacturers in China registered for this device type
171catalogue 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 | Deroyal Industries, 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, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2021-06-23 |
| Record revised | 2023-10-09 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Case of 200, case of 25, case of 400, case of 50, case of 100 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 60-3221 | In distribution | |
| 77-301705 | In distribution | |
| 77-400986 | In distribution | |
| 31-2221 | In distribution | |
| 32-3232 | In distribution | |
| 63-2221 | In distribution | |
| 62-3221 | In distribution | |
| 35-401095 | In distribution | |
| 77-300108 | In distribution | |
| 77-301711 | In distribution | |
| 31-3425-TP-06A | In distribution | |
| 77-300000 | In distribution | |
| RA-1186 | In distribution | |
| 31-3123 | In distribution | |
| 77-400176 | In distribution | |
| 35-401066 | In distribution | |
| 60-2123 | In distribution | |
| PXAK2066 | In distribution | |
| 60-3223 | In distribution | |
| 60-1L33 | In distribution | |
| 301748 | In distribution | |
| 31-3231 | In distribution | |
| 77-300008 | In distribution | |
| 77-301715 | In distribution | |
| 301746 | In distribution | |
| 60-2221 | In distribution | |
| 77-300112 | In distribution | |
| 12-001759 | In distribution | |
| 77-310106 | In distribution | |
| 60-3025 | In distribution | |
| 30-1234-AM | In distribution | |
| 60-3425TP-20 | In distribution | |
| 31-1225 | In distribution | |
| 77-301703 | In distribution | |
| 60-3122 | In distribution | |
| 77-400072 | In distribution | |
| 77-400595 | In distribution | |
| 301747 | In distribution | |
| 60-4231 | In distribution | |
| 79-401110 | In distribution | |
| 35-400756 | In distribution | |
| 301730 | In distribution | |
| 301732 | In distribution | |
| 77-301702 | In distribution | |
| 77-301709 | In distribution | |
| 77-310101 | In distribution | |
| 60-3225 | In distribution | |
| 77-310134 | In distribution | |
| 32-2232 | In distribution | |
| 31-2121 | In distribution | |
| 12-001775 | In distribution | |
| 31-2123 | In distribution | |
| 30-2232-AM | In distribution | |
| 77-301700 | In distribution | |
| 77-300007 | In distribution | |
| 301743 | In distribution | |
| 77-300115 | In distribution | |
| 77-300009 | In distribution | |
| 60-3125 | In distribution | |
| 35-400783 | In distribution | |
| 60-4225 | In distribution | |
| 301734 | In distribution | |
| 77-301708 | In distribution | |
| 301745 | In distribution | |
| 31-3223 | In distribution | |
| 31-3232-AM | In distribution | |
| 301728 | In distribution | |
| 60-3233 | In distribution | |
| 77-300133 | In distribution | |
| 77-400596 | In distribution | |
| CDI-32-1234 | In distribution | |
| 60-3121 | In distribution | |
| 77-301714 | In distribution | |
| 35-401081 | In distribution | |
| 32-2232-AM | In distribution | |
| 77-300002 | In distribution | |
| 77-301712 | In distribution | |
| 77-310102 | In distribution | |
| 30-1234 | In distribution | |
| 35-401076 | In distribution | |
| 15-1L36 | In distribution | |
| 77-301717 | In distribution | |
| 60-3221ZE | In distribution | |
| 77-301716 | In distribution | |
| 31-2232 | In distribution | |
| 30-3232 | In distribution | |
| 35-401063 | In distribution | |
| RA-1138 | In distribution | |
| 60-3425-TP-60 | In distribution | |
| 12-001776 | In distribution | |
| 77-301710 | In distribution | |
| 301742 | In distribution | |
| 60-3425-TP-48 | In distribution | |
| 77-300003 | In distribution | |
| 301729 | In distribution | |
| 31-4225 | In distribution | |
| 31-2225 | In distribution | |
| 301740 | In distribution | |
| 30-2232 | In distribution | |
| 31-2223 | In distribution | |
| 301749 | In distribution | |
| 77-310108 | In distribution | |
| 77-300006 | In distribution | |
| 77-400576 | In distribution | |
| 34-3221 | In distribution | |
| 60-1231 | In distribution | |
| 77-400781 | In distribution | |
| 31-1233 | In distribution | |
| 77-401010 | In distribution | |
| 32-2221 | In distribution | |
| 77-301701 | In distribution | |
| 77-310103 | In distribution | |
| 60-4125 | In distribution | |
| 60-3225ZE | In distribution | |
| 33-3233 | In distribution | |
| 60-3231 | In distribution | |
| 31-3225 | In distribution | |
| 35-401087 | In distribution | |
| 77-530653 | In distribution | |
| 31-3221 | In distribution | |
| 77-400594 | In distribution | |
| 60-1225 | In distribution | |
| 77-400593 | In distribution | |
| 79-401012 | In distribution | |
| 60-2021 | In distribution | |
| 77-310132 | In distribution | |
| 77-300134 | In distribution | |
| 301731 | In distribution | |
| CDI-32-1234-AM | In distribution | |
| 301726 | In distribution | |
| 60-3123 | In distribution | |
| 77-301713 | In distribution | |
| 60-2223 | In distribution | |
| 60-1233 | In distribution | |
| CDI-32-1233 | In distribution | |
| 12-001728 | In distribution | |
| 301733 | In distribution | |
| 12-000836 | In distribution | |
| 31-4231 | In distribution | |
| 77-400591 | In distribution | |
| PXAK1712 | In distribution | |
| 64-3221 | In distribution | |
| 301735 | In distribution | |
| 301744 | In distribution | |
| 60-2225 | In distribution | |
| 0203NC | In distribution | |
| 31-3221ZE | In distribution | |
| 60-2125 | In distribution | |
| 77-310135 | In distribution | |
| 77-400688 | In distribution | |
| 77-300114 | In distribution | |
| 77-301704 | In distribution | |
| 0203NA | In distribution | |
| RA-1142 | In distribution | |
| 30-3232-AM | In distribution | |
| 12-000236 | In distribution | |
| 60-3021 | In distribution | |
| 31-2125 | In distribution | |
| 77-300135 | In distribution | |
| 77-301707 | In distribution | |
| 77-400592 | In distribution | |
| 38-1L36 | In distribution | |
| 31-3225ZE | In distribution | |
| 77-400779 | In distribution | |
| 77-300146 | In distribution | |
| 12-001765 | In distribution | |
| 77-6798 | In distribution | |
| 77-310109 | In distribution | |
| 31-1231 | In distribution | |
| 31-3232 | In distribution | |
| 31-3121 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| 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
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.