DeRoyal
Single Transducer Kit w/Flush Device and 60" Tubing
3manufacturers in China registered for this device type
283catalogue numbers in this listing
1recall
Who Else Makes It
Concentrated in Zhejiang (1), Shanghai (1), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Elite Medtek(Jiangsu) Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 9 |
| GRI Medical & Electronic Technology Co., Ltd. | Jiaxing | Zhejiang | Contract manufacturer | 71 |
| Shanghai INT Medical Instruments Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 10 |
Record
| Listed by | Deroyal Industries, Inc., United States |
|---|---|
| FDA product code | OEQ |
| Device type | Angiography/Angioplasty Kit |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1650 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-09-24 |
| Record revised | 2021-08-26 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Case of 25, case of 4, case of 5, case of 3, case of 20, case of 6 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 89-8764 | In distribution | |
| 89-7194 | In distribution | |
| 89-9469 | In distribution | |
| 77-401006 | In distribution | |
| 89-9418 | In distribution | |
| 89-4660 | In distribution | |
| 89-8841 | In distribution | |
| 77-400994 | In distribution | |
| 77-400380 | In distribution | |
| 89-10022 | In distribution | |
| 77-400387 | In distribution | |
| 89-10955 | In distribution | |
| 89-9561 | In distribution | |
| 77-401040 | In distribution | |
| 89-3438 | In distribution | |
| 89-6388 | In distribution | |
| 89-8271 | In distribution | |
| 89-10108 | In distribution | |
| 89-7247 | In distribution | |
| 77-400993 | In distribution | |
| 77-400345 | In distribution | |
| 89-7609 | In distribution | |
| 89-7126 | In distribution | |
| 89-7284 | In distribution | |
| 35-400872 | In distribution | |
| 89-9920 | In distribution | |
| 89-9817 | In distribution | |
| 77-401107 | In distribution | |
| 77-400353 | In distribution | |
| 89-6503 | In distribution | |
| 77-400871 | In distribution | |
| 35-400918 | In distribution | |
| 89-3738 | In distribution | |
| 89-6197 | In distribution | |
| 77-300521 | In distribution | |
| 77-400889 | In distribution | |
| 89-9428 | In distribution | |
| 89-6380 | In distribution | |
| 89-7156 | In distribution | |
| 50-12127 | In distribution | |
| 89-7202 | In distribution | |
| 89-9156 | In distribution | |
| 89-8145 | In distribution | |
| 89-5564 | In distribution | |
| 77-401115 | In distribution | |
| 89-8338 | In distribution | |
| 89-4566 | In distribution | |
| 77-401048 | In distribution | |
| 35-401017 | In distribution | |
| 89-8864 | In distribution | |
| 89-7992 | In distribution | |
| 89-7903 | In distribution | |
| 89-7125 | In distribution | |
| 89-7770 | In distribution | |
| 89-9183 | In distribution | |
| 89-6145 | In distribution | |
| 77-401000 | In distribution | |
| 77-400368 | In distribution | |
| 77-401033 | In distribution | |
| 89-10477 | In distribution | |
| 77-401117 | In distribution | |
| 77-400278 | In distribution | |
| 89-10519 | In distribution | |
| 89-9717 | In distribution | |
| 89-7102 | In distribution | |
| 89-6896 | In distribution | |
| 89-6492 | In distribution | |
| 35-400356 | In distribution | |
| 89-7359 | In distribution | |
| 89-7400 | In distribution | |
| 89-10078 | In distribution | |
| 89-7432 | In distribution | |
| 89-6144 | In distribution | |
| 77-400494 | In distribution | |
| 89-7361 | In distribution | |
| 77-400590 | In distribution | |
| 89-10149 | In distribution | |
| 77-400999 | In distribution | |
| 77-400886 | In distribution | |
| 89-2824 | In distribution | |
| 89-7946 | In distribution | |
| 77-400940 | In distribution | |
| 89-8003 | In distribution | |
| 89-7425 | In distribution | |
| 89-10489 | In distribution | |
| 77-400857 | In distribution | |
| 77-401055 | In distribution | |
| 70-1911 | In distribution | |
| 35-400763 | In distribution | |
| 89-7006 | In distribution | |
| 35-401107 | In distribution | |
| 35-400979 | In distribution | |
| 35-400976 | In distribution | |
| 89-9117 | In distribution | |
| 89-3439 | In distribution | |
| 89-3561 | In distribution | |
| 89-7019 | In distribution | |
| 77-401062 | In distribution | |
| 79-401039 | In distribution | |
| 77-400932 | In distribution | |
| 89-3158 | In distribution | |
| 89-4758 | In distribution | |
| 77-401113 | In distribution | |
| 89-10070 | In distribution | |
| 89-9949 | In distribution | |
| 89-7375 | In distribution | |
| 89-10107 | In distribution | |
| 89-7214 | In distribution | |
| 77-400524 | In distribution | |
| 77-400784 | In distribution | |
| 89-5126 | In distribution | |
| 89-8465 | In distribution | |
| 77-400823 | In distribution | |
| 89-7322 | In distribution | |
| 79-401051 | In distribution | |
| 77-401032 | In distribution | |
| 89-9514 | In distribution | |
| 89-7398 | In distribution | |
| 89-3150 | In distribution | |
| 89-6734 | In distribution | |
| 77-400388 | In distribution | |
| 77-400374 | In distribution | |
| 89-6716 | In distribution | |
| 77-400992 | In distribution | |
| 89-8653 | In distribution | |
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| 89-9647 | In distribution | |
| 89-3185 | In distribution | |
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| 89-10367 | In distribution | |
| 89-7917 | In distribution | |
| 89-9984 | In distribution | |
| 77-400298 | In distribution | |
| 35-400901 | In distribution | |
| 94-0255 | In distribution | |
| 77-400619 | In distribution | |
| 89-6829 | In distribution | |
| 89-7477 | In distribution | |
| 89-10516 | In distribution | |
| 35-400935 | In distribution | |
| 79-401060 | In distribution | |
| 77-400720 | In distribution | |
| 89-9511 | In distribution | |
| 77-400347 | In distribution | |
| 77-400947 | In distribution | |
| 89-10467 | In distribution | |
| 89-9126 | In distribution | |
| 89-8478 | In distribution | |
| 89-10347 | In distribution | |
| 70-9907 | In distribution | |
| 77-400843 | In distribution | |
| 89-10155 | In distribution | |
| 79-401112 | In distribution | |
| 77-400588 | In distribution | |
| 89-8833 | In distribution | |
| 70-10784 | In distribution | |
| 77-400963 | In distribution | |
| 89-10614 | In distribution | |
| 89-7532 | In distribution | |
| 77-400683 | In distribution | |
| 77-400966 | In distribution | |
| 89-7447 | In distribution | |
| 89-7420 | In distribution | |
| 89-6992 | In distribution | |
| 89-7233 | In distribution | |
| 79-401114 | In distribution | |
| 89-10652 | In distribution | |
| 77-400626 | In distribution | |
| 50-13119 | In distribution | |
| 35-401053 | In distribution | |
| 77-300509 | In distribution | |
| 89-6542 | In distribution | |
| 77-400344 | In distribution | |
| 35-401029 | In distribution | |
| 89-9317 | In distribution | |
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| 89-9026 | In distribution | |
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| 89-8045 | In distribution | |
| 79-401091 | In distribution | |
| 77-400740 | In distribution | |
| 89-3043 | In distribution | |
| WS190A | In distribution | |
| 89-7613 | In distribution | |
| 89-4806 | In distribution | |
| 89-7401 | In distribution | |
| 99-0233 | In distribution | |
| 89-8558 | In distribution | |
| 89-10124 | In distribution | |
| 77-400674 | In distribution | |
| 77-400723 | In distribution | |
| 77-400822 | In distribution | |
| 89-6547 | In distribution | |
| 77-400453 | In distribution | |
| 89-2685 | In distribution | |
| 89-6548 | In distribution | |
| 89-8417 | In distribution | |
| 77-300522 | In distribution | |
| 89-6975 | In distribution | |
| 50-13483 | In distribution | |
| 89-8551 | In distribution | |
| 77-400765 | In distribution | |
| 89-10286 | In distribution | |
| 77-401022 | In distribution | |
| 89-8242 | In distribution | |
| 77-400310 | In distribution | |
| 77-400990 | In distribution | |
| 77-400262 | In distribution | |
| 89-7227 | In distribution | |
| 35-407158 | In distribution | |
| 89-8144 | In distribution | |
| 89-7462 | In distribution | |
| 89-3151 | In distribution | |
| 89-6149 | In distribution | |
| 77-400579 | In distribution | |
| 89-8878 | In distribution | |
| 89-9465 | In distribution | |
| 89-6556 | In distribution | |
| 89-8486 | In distribution | |
| 35-400946 | In distribution | |
| 89-7766 | In distribution | |
| 35-401106 | In distribution | |
| 89-9963 | In distribution | |
| 77-400385 | In distribution | |
| 89-10716 | In distribution | |
| 77-400452 | In distribution | |
| 89-6384 | In distribution | |
| 89-7092 | In distribution | |
| 77-400912 | In distribution | |
| 89-9468 | In distribution | |
| 89-4539 | In distribution | |
| 35-401052 | In distribution | |
| 77-400851 | In distribution | |
| 89-3877 | In distribution | |
| 89-9097 | In distribution | |
| 89-6465 | In distribution | |
| 89-10099 | In distribution | |
| 89-9476 | In distribution |
Showing 250 of 283 catalogue numbers.
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Cardinal Health | Cardinal Health 200, LLC | 20,409 |
| Merit Medical® | Merit Medical Systems, Inc. | 3,927 |
| Medline Industries, Inc. | Medline Industries, Inc. | 2,085 |
| ACS | American Contract Systems, Inc. | 428 |
| Aligned Medical Solutions | Aligned Medical Solutions | 120 |
| Regard™ | ROi CPS LLC | 57 |
| Stradis Healthcare | Stradis Healthcare | 33 |
| Regard™ | Resource Optimization & Innovation, L.L.C. | 23 |
| Namic | Medline Industries, Inc. | 21 |
| basixCOMPAK™ | Merit Medical Systems, Inc. | 8 |
| Stradis | Stradis Healthcare | 7 |
| AccessPLUS™ | Merit Medical Systems, Inc. | 6 |
Showing 12 of 49. All products under Angiography/Angioplasty Kit
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Deroyal Industries, Inc. | UDI-DI | 2023-05-30 | Class II | Process control | The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside. | 306 packs |
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.