What is FDA product code OEV?

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™ · Cardiopulmonary Resuscitation Aid Kit → Anesthesiology

Name: Regard™
Brand: Regard™

3manufacturers in China registered for this device type

41catalogue numbers in this listing

1recall

Who Else Makes It

All of them in Fujian. One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code OEV
Manufacturer	City	Province	Registered as	Device types
Ambu Limited	Xiang Yu F.T.Z., Xiamen	Fujian	Contract manufacturer	11
GaleMed (Xiamen) Co., Ltd.	Xiamen	Fujian	Contract manufacturer	33
Xiamen Compower Medical Tech. Co., Ltd.	Xiamen	Fujian	Contract manufacturer	9

Record

Regulatory record for Regard™
Listed by	ROi CPS LLC
FDA product code	OEV
Device type	Cardiopulmonary Resuscitation Aid Kit
Device class	Class 2
Regulation	21 CFR 868.5915
Premarket notification	Exempt
Record published	2024-10-21
Record revised	2025-04-03 (version 3)

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 7, pack of 2, pack of 8, pack of 10, pack of 14, pack of 12
Distribution end date	2025-06-05

Catalogue Numbers

Catalogue numbers for Regard™
Catalogue number	Size	Status
AN01246B		Withdrawn
AN01251		Withdrawn
AN01246A		Withdrawn
AN01253		Withdrawn
AN01265		Withdrawn
AN01185		Withdrawn
AN01312		Withdrawn
AN01316		Withdrawn
AN01247C		Withdrawn
AN01255A		Withdrawn
AN01249B		Withdrawn
AN01266		Withdrawn
AN01251A		Withdrawn
AN01235		Withdrawn
AN01247B		Withdrawn
AN01247		Withdrawn
AN01313		Withdrawn
AN01255		Withdrawn
AN01314		Withdrawn
AN01257		Withdrawn
AN01234A		Withdrawn
AN01256		Withdrawn
AN01234		Withdrawn
GS00813		Withdrawn
AN01268		Withdrawn
AN01252		Withdrawn
AN01310		Withdrawn
AN01315		Withdrawn
AN01249A		Withdrawn
AN01233		Withdrawn
AN01250		Withdrawn
AN01246		Withdrawn
AN01309		Withdrawn
AN01186		Withdrawn
AN01236		Withdrawn
AN01311		Withdrawn
AN01249		Withdrawn
AN01236A		Withdrawn
AN01247A		Withdrawn
AN01267		Withdrawn
AN01269		Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Ambu® Spur® II Adult Resuscitator	Ambu A/S	97
Ambu® Spur® II Pediatric Resuscitator	Ambu A/S	88
AirLife	Carefusion	79
AirLife™	Airlife, Inc.	38
Ambu® Spur® II Infant Resuscitator	Ambu A/S	23
SuperNO2VA	Airlife, Inc.	6
Mark IV Baby Resuscitator	Ambu A/S	5
Curaplex	Bound Tree Medical, LLC	3
Mark IV Resuscitatorwith single shutter patient valve	Ambu A/S	2
EMI	Xiamen Compower Medical Tech. Co., Ltd.	1
Spur® II Infant Resuscitator	Ambu A/S	1
Ambu® Spur® II Pedi. BAG Resvr.	Ambu A/S	1

Showing 12 of 16. All products under Cardiopulmonary Resuscitation Aid Kit

Recalls

1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.

Recalls referencing this product code
Initiated	FDA class	Root cause	Reason	Quantity	Closed
2020-05-19	Class II	Error in labeling	Roi CPS, LLC has become aware of a labeling error that affects select custom procedure kits. The kits are labeled with an expiration date that is later than that of the soonest kit component to expire in the kits.	200 kits	2020-09-01

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™