What is FDA product code OES?

This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

Regard™ · Cardiac Catheterization Kit → Cardiovascular

Name: Regard™
Brand: Regard™

1manufacturer

138catalogue numbers in this listing

1recall

Who Else Makes It

Registered in Zhejiang.

Chinese manufacturers registered for FDA product code OES
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	ROi CPS LLC
FDA product code	OES
Device type	Cardiac Catheterization Kit
Device class	Class 2
Regulation	21 CFR 870.1200
Premarket notification	Exempt
Record published	2020-01-17
Record revised	2025-04-14 (version 5)

Specifications

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 2, pack of 4, pack of 8, pack of 5
Distribution end date	2026-01-13
UDI direct marking	Exempt

Catalogue Numbers

Catalogue numbers for Regard™
Catalogue number	Size	Status
OB00763I		Withdrawn
HT00468H		Withdrawn
HT00253G		Withdrawn
HT00391O		Withdrawn
HT01178B		Withdrawn
HT01091		Withdrawn
HT00145X		Withdrawn
HT00967B		Withdrawn
HT00434K		Withdrawn
HT00145V		Withdrawn
HT00957B		Withdrawn
HT00997C		Withdrawn
HT00252G		Withdrawn
HT00074Z		Withdrawn
HT01091C		Withdrawn
HT00434L		Withdrawn
HT00143S		Withdrawn
HT00967C		Withdrawn
HT01091B		Withdrawn
HT00013O		Withdrawn
HT00423K		Withdrawn
HT00052Q		Withdrawn
HT00145R		Withdrawn
HT00271G		Withdrawn
HT00374K		Withdrawn
HT00013Q		Withdrawn
HT00052P		Withdrawn
HT00391Q		Withdrawn
HT00235L		Withdrawn
HT00145U		Withdrawn
HT00391M		Withdrawn
HT00252H		Withdrawn
HT00375J		Withdrawn
HT00434M		Withdrawn
HT00333H		Withdrawn
HT00334I		Withdrawn
HT00253F		Withdrawn
HT01008C		Withdrawn
HT00908D		Withdrawn
HT00331H		Withdrawn
HT00075U		Withdrawn
HT00329I		Withdrawn
HT00375K		Withdrawn
HT00271I		Withdrawn
HT00468J		Withdrawn
HT01008E		Withdrawn
HT00051P		Withdrawn
HT00908C		Withdrawn
HT00145S		Withdrawn
HT01170D		Withdrawn
HT00074Y		Withdrawn
HT00423J		Withdrawn
HT00235M		Withdrawn
HT01025D		Withdrawn
HT00074X		Withdrawn
HT00951B		Withdrawn
HT01179		Withdrawn
HT00267E		Withdrawn
HT00374M		Withdrawn
HT00386J		Withdrawn
HT00434N		Withdrawn
HT00326Q		Withdrawn
HT00952A		Withdrawn
HT00374J		Withdrawn
HT01169		Withdrawn
HT00326O		Withdrawn
HT01025F		Withdrawn
HT00145Q		Withdrawn
HT01179A		Withdrawn
HT01025G		Withdrawn
HT00952C		Withdrawn
HT00386I		Withdrawn
HT00468I		Withdrawn
HT00434J		Withdrawn
HT00253I		Withdrawn
HT00454F		Withdrawn
HT00338L		Withdrawn
HT00967A		Withdrawn
GS00839A		Withdrawn
HT00462N		Withdrawn
HT00253H		Withdrawn
HT00143R		Withdrawn
HT00051Q		Withdrawn
HT01025E		Withdrawn
HT00013P		Withdrawn
HT00239F		Withdrawn
HT00271H		Withdrawn
HT00957C		Withdrawn
HT01025H		Withdrawn
HT01179B		Withdrawn
HT01169A		Withdrawn
HT00051R		Withdrawn
HT00908B		Withdrawn
HT00051O		Withdrawn
HT00997E		Withdrawn
HT00462O		Withdrawn
HT00465K		Withdrawn
HT00239G		Withdrawn
HT01008D		Withdrawn
HT00454G		Withdrawn
HT00143U		Withdrawn
HT00374N		Withdrawn
HT00951C		Withdrawn
HT00605F		Withdrawn
HT00052O		Withdrawn
HT00825D		Withdrawn
HT00328K		Withdrawn
HT00326N		Withdrawn
HT00465L		Withdrawn
HT01025C		Withdrawn
HT00908E		Withdrawn
HT00051S		Withdrawn
HY00145T		Withdrawn
HT01091A		Withdrawn
HT00952B		Withdrawn
HT00075V		Withdrawn
HT00145W		Withdrawn
HT00235N		Withdrawn
HT00143T		Withdrawn
HT00468G		Withdrawn
HT00908E		Withdrawn
HT00326P		Withdrawn
HT00605E		Withdrawn
HT00267D		Withdrawn
HT01178		Withdrawn
HT00252I		Withdrawn
HT00183Q		Withdrawn
HT00051N		Withdrawn
HT00271F		Withdrawn
HT00183R		Withdrawn
HT00997D		Withdrawn
HT00235O		Withdrawn
HT00074W		Withdrawn
HT00374L		Withdrawn
HT00391N		Withdrawn
HT00391P		Withdrawn
HT01178A		Withdrawn
HT00468F		Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Medline Industries, Inc.	Medline Industries, Inc.	7,486
Cardinal Health	Cardinal Health 200, LLC	2,706
Avid TruCustom	Avid Medical, Inc.	1,173
Centurion	Centurion Medical Products Corporation	1,077
Halyard	Avid Medical, Inc.	1,032
Medline Industries, Inc.	Centurion Medical Products Corporation	775
Medline	Medline Industries, Inc.	465
ACS	American Contract Systems, Inc.	344
Regard™	Resource Optimization & Innovation, L.L.C.	79
Aligned Medical Solutions	Aligned Medical Solutions	72
Centurion Medical Products Corp	Medline Industries, Inc.	24
Namic	Medline Industries, Inc.	14

Showing 12 of 18. All products under Cardiac Catheterization Kit

Recalls Naming This Product

1 recall names this product by its own identifier, the UDI on its label.

Recalls naming the identifiers of Regard™
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity
ROi CPS LLC	UDI-DI	2023-03-22	Class II	Nonconforming Material/Component	The recalling firm was notified by their supplier that the light handle covers may separate from the light handle and fall off during use. The light handle covers are a kit component.	322 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.

Regard™