Data / Medical devices / Cardiopulmonary Resuscitation Aid Kit
Cardiopulmonary Resuscitation Aid Kit (OEV): 13 FDA-registered makers in 5 countries
13 establishments in 5 countries are registered with the FDA to make Cardiopulmonary Resuscitation Aid Kit (product code OEV, Class 2, 21 CFR 868.5915). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 2 recall events (1 Class I). FDA data exported November 2, 2026.
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- Product code
- OEV
- Device class
- 2
- Regulation
- 868.5915
- Medical specialty
- Anesthesiology
Makers by country
| Country | Makers |
|---|---|
| United States | 4 |
| China | 3 |
| Mexico | 3 |
| India | 2 |
| Denmark | 1 |
Makers of Cardiopulmonary Resuscitation Aid Kit
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| AMBU Limited | XIANG YU F.T.Z., XIAMEN Fujian, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ambu A/S | Ballerup Hovedstaden, Denmark | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ambu Mexico Operations S.A. DE C.V. | Ciudad Juarez Chihuahua, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bound Tree Medical, LLC | Grand Prairie, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cardinal Health 200, LLC | El Paso, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Convertors de Mexico S. de R.L. de C.V | CD.JUAREZ Chihuahua, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GaleMed (Xiamen) Co., Ltd. | XIAMEN Fujian, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mark Enterprises | Nashik Maharashtra, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Marken Healthtech Limited | NASHIK Maharashtra, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| MEDLINE INDUSTRIES, LP - Northfield | Northfield, IL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Productos Urologos De Mexico S.A. De C.V. | MEXICALI Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| SunMed Group Holdings, LLC | Grand Rapids, MI, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xiamen Compower Medical Tech. Co., Ltd. | Xiamen Fujian, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.