Ambu® Spur® II Pediatric Resuscitator
w/ Expiratory Filter, Manometer & PEEP valve
3manufacturers in China registered for this device type
88catalogue 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 | 2024-02-20 |
| Record revised | 2026-01-30 (version 3) |
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 | Storage environment temperature 15 to 25 °C; Handling environment temperature -18 to 50 °C |
| Packaging | Pack of 6, pack of 12, case of 12 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 530213830 | In distribution | |
| 530213034 | In distribution | |
| 531614051 | Pediatric | In distribution |
| 530213030 | In distribution | |
| 530611000 | Pediatric | In distribution |
| 530211000 | Pediatric | In distribution |
| 531613049 | In distribution | |
| 530212000B | Pediatric | In distribution |
| 530613031 | In distribution | |
| 530612800 | In distribution | |
| 531613071 | In distribution | |
| 530600001 | Pediatric | In distribution |
| 530618000 | Pediatric | In distribution |
| 531612000 | Pediatric | In distribution |
| 530613000 | Pediatric | In distribution |
| 530212000 | Pediatric | In distribution |
| 530214000B | Pediatric | In distribution |
| 530213859 | In distribution | |
| 531613016 | In distribution | |
| 530213001 | Pediatric | In distribution |
| 531614030 | Pediatric | In distribution |
| 531615000 | Pediatric | In distribution |
| 531613001 | Pediatric | In distribution |
| 530212001 | Pediatric | In distribution |
| 531613047 | In distribution | |
| 530215000 | Pediatric | In distribution |
| 531613055 | In distribution | |
| 530615031 | In distribution | |
| 530612010 | In distribution | |
| 531613000 | Pediatric | In distribution |
| 530613001 | Pediatric | In distribution |
| 530615000 | Pediatric | In distribution |
| 530215031 | In distribution | |
| 531613830 | In distribution | |
| 530616000 | Pediatric | In distribution |
| 530213000B | Pediatric | In distribution |
| 530614017 | In distribution | |
| 531613031 | In distribution | |
| 530212025 | Pediatric | In distribution |
| 530215000B | Pediatric | In distribution |
| 531613010 | Pediatric | In distribution |
| 531613030 | In distribution | |
| 530619000 | Pediatric | In distribution |
| 530613034 | In distribution | |
| 530613831 | In distribution | |
| 530613800 | In distribution | |
| 530213031 | Pediatric | In distribution |
| 530613054 | In distribution | |
| 530613057 | Pediatric | In distribution |
| 530613073 | In distribution | |
| 530619031 | In distribution | |
| 530613017 | In distribution | |
| 530214034 | In distribution | |
| 531600051 | Pediatric | In distribution |
| 530612054 | In distribution | |
| 530213010 | Pediatric | In distribution |
| 530214000 | Pediatric | In distribution |
| 530212033 | In distribution | |
| 530218047 | In distribution | |
| 530213000 | Pediatric | In distribution |
| 530215001 | In distribution | |
| 530213033 | Pediatric | In distribution |
| 531612035 | Pediatric | In distribution |
| 530613830 | In distribution | |
| 530614800 | In distribution | |
| 530635031 | In distribution | |
| 531614000 | Pediatric | In distribution |
| 530233000 | Pediatric | In distribution |
| 530613030 | In distribution | |
| 531614026 | Pediatric | In distribution |
| 530639011 | Pediatric | In distribution |
| 530612001 | Pediatric | In distribution |
| 530613071 | In distribution | |
| 530615030 | In distribution | |
| 531615010 | Pediatric | In distribution |
| 531613043 | In distribution | |
| 530613055 | In distribution | |
| 530619016 | In distribution | |
| 530613019 | In distribution | |
| 530200016 | In distribution | |
| 531611000 | Pediatric | In distribution |
| 530614030 | In distribution | |
| 531616000 | In distribution | |
| 531613017 | In distribution | |
| 530213011 | Pediatric | In distribution |
| 530612000 | Pediatric | In distribution |
| 530613025 | Pediatric | In distribution |
| 530614000 | Pediatric | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ambu® Spur® II Adult Resuscitator | Ambu A/S | 97 |
| 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.