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.

Mark IV Resuscitatorwith Single Shutter Patient Valve · Cardiopulmonary Resuscitation Aid Kit → Anesthesiology

Name: Mark IV Resuscitatorwith single shutter patient valve
Brand: Mark IV Resuscitatorwith single shutter patient valve

3manufacturers in China registered for this device type

2catalogue 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 Mark IV Resuscitatorwith single shutter patient valve
Listed by	Ambu A/S, Denmark
FDA product code	OEV
Device type	Cardiopulmonary Resuscitation Aid Kit
Device class	Class 2
Regulation	21 CFR 868.5915
Establishment	Specification developer, Private-label distributor, Manufacturer, Exporter
Premarket notification	Exempt
Record published	2016-12-19
Record revised	2024-09-17 (version 3)

Specifications

Specifications
MRI safety	MR Conditional
Sterilisation	Moist Heat or Steam Sterilization
Prescription	Prescription only
Supplied as a kit	Yes
Label carries	lot or batch number, expiry date
Storage	Handling environment temperature -18 to 50 °C; Storage environment temperature -18 to 50 °C
Packaging	Pack of 6

Catalogue Numbers

Catalogue numbers for Mark IV Resuscitatorwith single shutter patient valve
Catalogue number	Size	Status
304002000	Adult	In distribution
304009000	Adult	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
SuperNO2VA	Airlife, Inc.	6
Mark IV Baby Resuscitator	Ambu A/S	5
Curaplex	Bound Tree Medical, LLC	3
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

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.

Mark IV Resuscitatorwith Single Shutter Patient Valve

Who Else Makes It

Record

Specifications

Catalogue Numbers

Same Product Code

Where China Actually Supplies