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.

SuperNO2VA · Cardiopulmonary Resuscitation Aid Kit → Anesthesiology

Name: SuperNO2VA
Brand: SuperNO2VA

3manufacturers in China registered for this device type

6catalogue numbers in this listing

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 SuperNO2VA
Listed by	Airlife, Inc., United States
FDA product code	OEV
Device type	Cardiopulmonary Resuscitation Aid Kit
Device class	Class 2
Regulation	21 CFR 868.5915
Premarket notification	Exempt
Record published	2025-02-14
Record revised	2025-04-17 (version 3)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Single use	Yes
Prescription	Prescription only
Latex	Labelled latex-free
Label carries	lot or batch number, expiry date
Packaging	Case of 20

Catalogue Numbers

Catalogue numbers for SuperNO2VA
Catalogue number	Size	Status
SSM-20		In distribution
SSEL-20		In distribution
SSM-20		In distribution
SSL-20		In distribution
SSEM-20		In distribution
SSL-20		In distribution

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
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 Naming This Product

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

Recalls naming the identifiers of SuperNO2VA
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason
SunMed Group Holdings, LLC	UDI-DI	2023-10-11	Class II	Device Design	A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.

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.

SuperNO2VA