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.

Anesthesiology › TherapeuticCardiopulmonary Resuscitation Aid Kit

Regard™

Name: Regard™
Brand: Regard™

Catalogue number GS0813, listed by Resource Optimization & Innovation, L.L.C., under Cardiopulmonary Resuscitation Aid Kit. 3 manufacturers in China are registered for this product code.

Registry build 21.09.26

3manufacturers in China registered for this device type

1catalogue number

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	Resource Optimization & Innovation, L.L.C.
FDA product code	OEV
Device type	Cardiopulmonary Resuscitation Aid Kit
Device class	Class 2
Regulation	21 CFR 868.5915
Premarket notification	Exempt
Record published	2016-12-20
Record revised	2024-04-03 (version 6)

Specifications

Specifications
MRI safety	MR Safe
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 8
Distribution end date	2020-08-26

Catalogue Numbers

Catalogue numbers for Regard™
Catalogue number	Size	Status
GS0813		Withdrawn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
Regard™	ROi CPS LLC	41
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

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