Ambu® Spur® II Pedi. BAG Resvr.
w/CO2 Detector
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.
| 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
| 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 | 2024-02-20 |
| Record revised | 2026-01-30 (version 2) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Single use | Yes |
| 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 15 to 25 °C |
| Packaging | Pack of 12 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 530213800 | In distribution |
Same 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.