Regard™
Special Procedures Imaging
3manufacturers in China registered for this device type
57catalogue 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 | ROi CPS LLC |
|---|---|
| FDA product code | OEQ |
| Device type | Angiography/Angioplasty Kit |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1650 |
| Premarket notification | Exempt |
| Record published | 2022-12-13 |
| Record revised | 2021-01-07 (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 |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 3, pack of 4, pack of 2, pack of 6, pack of 8, pack of 24 |
| Distribution end date | 2025-06-05 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| HT00907B | Withdrawn | |
| HT01015 | Withdrawn | |
| HT00376J | Withdrawn | |
| HT00856B | Withdrawn | |
| HT00376H | Withdrawn | |
| HT00076P | Withdrawn | |
| HT01060A | Withdrawn | |
| HT00905B | Withdrawn | |
| HT01060B | Withdrawn | |
| SP01209A | Withdrawn | |
| HT00856C | Withdrawn | |
| HT00906D | Withdrawn | |
| HT00317F | Withdrawn | |
| HT00990D | Withdrawn | |
| HT00001R | Withdrawn | |
| HT00227K | Withdrawn | |
| SP01063C | Withdrawn | |
| HT01040E | Withdrawn | |
| HT00317G | Withdrawn | |
| HT00990C | Withdrawn | |
| HT00990G | Withdrawn | |
| HT00001S | Withdrawn | |
| HT00026N | Withdrawn | |
| HT00907A | Withdrawn | |
| HT00029P | Withdrawn | |
| HT00992E | Withdrawn | |
| HT00992F | Withdrawn | |
| HT00906C | Withdrawn | |
| GS00158J | Withdrawn | |
| CV00364F | Withdrawn | |
| HT00227I | Withdrawn | |
| SP01063B | Withdrawn | |
| HT00992D | Withdrawn | |
| CV00364E | Withdrawn | |
| HT00317H | Withdrawn | |
| HT00227J | Withdrawn | |
| HT00376I | Withdrawn | |
| HT00905A | Withdrawn | |
| HT01040D | Withdrawn | |
| HT00376G | Withdrawn | |
| HT00026L | Withdrawn | |
| HT00029Q | Withdrawn | |
| HT00990F | Withdrawn | |
| HT00001P | Withdrawn | |
| HT00001Q | Withdrawn | |
| SP01063A | Withdrawn | |
| SP01063D | Withdrawn | |
| GS00158L | Withdrawn | |
| HT00076O | Withdrawn | |
| HT00906B | Withdrawn | |
| HT00001O | Withdrawn | |
| HT00026M | Withdrawn | |
| HT00990E | Withdrawn | |
| GS00158K | Withdrawn | |
| HT01015A | Withdrawn | |
| HT00016P | Withdrawn | |
| HT01040F | 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 |
| 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 |
|---|---|---|---|---|---|---|
| ROi CPS LLC | UDI-DI | 2024-07-24 | Class II | Process control | Medical convenience kits were distributed with Merit syringes (manufactured by Jiangsu Shenli Medical Production) which were subsequently recalled. | 3387 kits |
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.