Ambu® Spur® II Adult Resuscitator
w/ PEEP Valve, Manometer, VII Exhalation Filter & Mask
3manufacturers in China registered for this device type
97catalogue 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 | 2024-02-02 |
| Record revised | 2025-05-06 (version 4) |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Handling environment temperature -18 to 50 °C; Storage environment temperature 15 to 25 °C |
| Packaging | Pack of 6, pack of 12, case of 12, case of 6 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 520611072 | In distribution | |
| 520611011 | Adult | In distribution |
| 523611000 | Adult | In distribution |
| 520611000E | In distribution | |
| 520611100 | Adult | In distribution |
| 520611101 | Adult | In distribution |
| 523600051 | Adult | In distribution |
| 520211010 | Adult | In distribution |
| 520611034 | Adult | In distribution |
| 520211001 | Adult | In distribution |
| 524611000 | Adult | In distribution |
| 523611054 | In distribution | |
| 523611017 | In distribution | |
| 521611020 | In distribution | |
| 520231000 | Adult | In distribution |
| 520611010 | Adult | In distribution |
| 521611048 | In distribution | |
| 523211000 | Adult | In distribution |
| 524611011 | In distribution | |
| 521611000E | In distribution | |
| 520611701 | In distribution | |
| 520214000E | In distribution | |
| 520611001 | Adult | In distribution |
| 523611031 | In distribution | |
| 520211000B | Adult | In distribution |
| 520611019 | In distribution | |
| 520211034 | Adult | In distribution |
| 524611001 | Adult | In distribution |
| 521611038 | In distribution | |
| 523617051 | Adult | In distribution |
| 523211001 | Adult | In distribution |
| 523611001 | In distribution | |
| 520211001E | In distribution | |
| 520211048 | In distribution | |
| 520211000E | In distribution | |
| 520211000 | Adult | In distribution |
| 523616017 | In distribution | |
| 521611071 | In distribution | |
| 521611001 | Adult | In distribution |
| 523611031E | In distribution | |
| 523611700 | In distribution | |
| 521611013 | Adult | In distribution |
| 522611010 | Adult | In distribution |
| 520211071 | Adult | In distribution |
| 520211011 | Adult | In distribution |
| 521611010 | Adult | In distribution |
| 520211014 | In distribution | |
| 520211061 | Adult | In distribution |
| 521611037 | Adult | In distribution |
| 520211038 | Adult | In distribution |
| 520212033 | Adult | In distribution |
| 520611000 | Adult | In distribution |
| 523211000E | In distribution | |
| 521611049 | In distribution | |
| 524611031 | In distribution | |
| 520611048 | In distribution | |
| 520211758 | In distribution | |
| 520611033AF | In distribution | |
| 523611061 | Adult | In distribution |
| 520611066 | Adult | In distribution |
| 523611051 | In distribution | |
| 520211010E | In distribution | |
| 523611751 | In distribution | |
| 521611700 | In distribution | |
| 520614000 | Adult | In distribution |
| 523211001E | In distribution | |
| 520211000BE | In distribution | |
| 523211016 | In distribution | |
| 523632016 | In distribution | |
| 520611014 | Adult | In distribution |
| 524611047 | In distribution | |
| 523611030E | In distribution | |
| 521611012 | Adult | In distribution |
| 520615000 | Adult | In distribution |
| 520211041 | Adult | In distribution |
| 520612000 | Adult | In distribution |
| 520212000 | Adult | In distribution |
| 521611018 | Adult | In distribution |
| 523611057 | In distribution | |
| 522611000 | Adult | In distribution |
| 520200000 | Adult | In distribution |
| 520217000 | Adult | In distribution |
| 521611000 | Adult | In distribution |
| 523611730 | In distribution | |
| 520214000 | Adult | In distribution |
| 520211033 | Adult | In distribution |
| 521611011 | In distribution | |
| 521612000 | Adult | In distribution |
| 521600000 | Adult | In distribution |
| 520611700 | In distribution | |
| 523631011 | Adult | In distribution |
| 524614000 | In distribution | |
| 523611030 | In distribution | |
| 520616000 | Adult | In distribution |
| 520212001 | Adult | In distribution |
| 520600001 | Adult | In distribution |
| 520611074 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| 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.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Ambu Limited | UDI-DI | 2025-07-09 | Class I | Equipment maintenance | Potential for the manometer port being blocked rendering the manometer non-functional. | 87,156 units |
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.