Regard™

72 catalogue numbers from CV1059, listed by Resource Optimization & Innovation, L.L.C., under Cardiovascular Procedure Kit. 1 manufacturer in China is registered for this product code.

Registry build 21.09.26
1manufacturer
72catalogue numbers in this listing

Who Else Makes It

Registered in Zhejiang.

Chinese manufacturers registered for FDA product code OEZ
Manufacturer City Province Registered as Device types
GRI Medical & Electronic Technology Co., Ltd. Jiaxing Zhejiang Contract manufacturer 71

Record

Regulatory record for Regard™
Listed by Resource Optimization & Innovation, L.L.C.
FDA product code OEZ
Device type Cardiovascular Procedure Kit
Device class Class 2
Regulation 21 CFR 870.1200
Premarket notification Exempt
Record published 2018-10-23
Record revised 2020-08-27 (version 5)

Specifications

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 2, pack of 3, pack of 4, pack of 10, pack of 20
Distribution end date 2020-08-26

Catalogue Numbers

Catalogue numbers for Regard™
Catalogue number Size Status
CV1059 Withdrawn
CV0440 Withdrawn
CV0804 Withdrawn
HT0330 Withdrawn
CV0965 Withdrawn
CV0054 Withdrawn
CV0913 Withdrawn
CV0929 Withdrawn
CV0207 Withdrawn
CV0932 Withdrawn
CV0806 Withdrawn
CV0335 Withdrawn
CV0289 Withdrawn
CV1005 Withdrawn
CV0625 Withdrawn
CV0494 Withdrawn
CV0190 Withdrawn
CV0552 Withdrawn
CV0425 Withdrawn
CV0680 Withdrawn
CV0978 Withdrawn
CV0247 Withdrawn
HT0144 Withdrawn
CV0079 Withdrawn
CV0500 Withdrawn
CV0659 Withdrawn
CV0479 Withdrawn
CV0339 Withdrawn
CV0820 Withdrawn
CV0368 Withdrawn
CV0332 Withdrawn
CV0830 Withdrawn
CV0426 Withdrawn
CV0189 Withdrawn
HT1069 Withdrawn
CV0404 Withdrawn
CV1038 Withdrawn
CV0634 Withdrawn
CV0654 Withdrawn
CV0443 Withdrawn
OR0379 Withdrawn
CV0755 Withdrawn
CV0956 Withdrawn
CV0188 Withdrawn
CV0758 Withdrawn
CV0337 Withdrawn
CV0214 Withdrawn
CV0852 Withdrawn
CV0080 Withdrawn
CV0741 Withdrawn
CV0979 Withdrawn
CV0670 Withdrawn
CV0361 Withdrawn
CV0568 Withdrawn
CV0805 Withdrawn
CV0261 Withdrawn
CV0966 Withdrawn
SP1079 Withdrawn
CV0851 Withdrawn
CV0245 Withdrawn
CV1003 Withdrawn
CV0283 Withdrawn
CV0414 Withdrawn
CV0213 Withdrawn
CV0661 Withdrawn
CV0033 Withdrawn
OR0994 Withdrawn
HT0161 Withdrawn
CV0482 Withdrawn
CV0407 Withdrawn
CV0256 Withdrawn
CV0077 Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Cardinal Health Cardinal Health 200, LLC 40,731
Medline Industries, Inc. Medline Industries, Inc. 17,468
Avid TruCustom Avid Medical, Inc. 2,785
Namic Medline Industries, Inc. 2,718
Merit Medical® Merit Medical Systems, Inc. 2,399
Halyard Avid Medical, Inc. 2,108
ACS American Contract Systems, Inc. 1,540
Medline Medline Industries, Inc. 428
Stradis Healthcare Stradis Healthcare 263
Regard™ ROi CPS LLC 192
Stradis Stradis Healthcare 108
Centurion Medical Products Corp Medline Industries, Inc. 51

Showing 12 of 52. All products under Cardiovascular Procedure 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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer