Ambu® Spur® II Infant Resuscitator
23 catalogue numbers from 544212001, listed by Ambu A/S, Denmark, under Cardiopulmonary Resuscitation Aid Kit. 3 manufacturers in China are registered for this product code.
3manufacturers in China registered for this device type
23catalogue 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.
| 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 | 2023-12-22 |
| 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 |
|---|---|---|
| 544212001 | Infant | In distribution |
| 544211030 | Infant | In distribution |
| 544216069 | In distribution | |
| 544211001 | Infant | In distribution |
| 544212017 | In distribution | |
| 544212000 | Infant | In distribution |
| 544212031 | Infant | In distribution |
| 540211000 | Infant | In distribution |
| 540212000 | Infant | In distribution |
| 540216031 | Infant | In distribution |
| 540212031 | Infant | In distribution |
| 544211000 | Infant | In distribution |
| 544216031 | Infant | In distribution |
| 544211047 | Infant | In distribution |
| 540212030 | Infant | In distribution |
| 544211031 | Infant | In distribution |
| 540211031 | Infant | In distribution |
| 540212010 | Infant | In distribution |
| 544216030 | Infant | In distribution |
| 540211001 | Infant | In distribution |
| 544212030 | Infant | In distribution |
| 544200000 | Infant | In distribution |
| 540211030 | Infant | 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 |
| 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 |
| 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.