Regard™
23 catalogue numbers from CV0364, listed by Resource Optimization & Innovation, L.L.C., under Angiography/Angioplasty Kit. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
23catalogue numbers in this listing
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 | Resource Optimization & Innovation, L.L.C. |
|---|---|
| FDA product code | OEQ |
| Device type | Angiography/Angioplasty Kit |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1650 |
| Premarket notification | Exempt |
| Record published | 2016-12-05 |
| Record revised | 2020-08-27 (version 4) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 3, pack of 4, pack of 2, pack of 10, pack of 8, pack of 6 |
| Distribution end date | 2020-08-26 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CV0364 | Withdrawn | |
| HT0990 | Withdrawn | |
| HT0227 | Withdrawn | |
| HT0016 | Withdrawn | |
| HT0026 | Withdrawn | |
| HT1040 | Withdrawn | |
| HT0550 | Withdrawn | |
| HT0992 | Withdrawn | |
| HT1060 | Withdrawn | |
| HT0001 | Withdrawn | |
| HT0029 | Withdrawn | |
| HT0906 | Withdrawn | |
| HT0760 | Withdrawn | |
| HT1074 | Withdrawn | |
| SP1063 | Withdrawn | |
| HT0856 | Withdrawn | |
| HT1015 | Withdrawn | |
| GS0158 | Withdrawn | |
| HT0907 | Withdrawn | |
| HT0076 | Withdrawn | |
| HT0376 | Withdrawn | |
| HT0317 | Withdrawn | |
| HT0905 | Withdrawn |
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 |
| DeRoyal | Deroyal Industries, Inc. | 283 |
| Aligned Medical Solutions | Aligned Medical Solutions | 120 |
| Regard™ | ROi CPS LLC | 57 |
| Stradis Healthcare | Stradis Healthcare | 33 |
| 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
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.