Spur® Pediatric Resuscitator
SPUR II Ped Bag Res, Pop, Tod Mask, Mano, PEEP, Exp Filter
8manufacturers in China registered for this device type
4catalogue numbers in this listing
4510(k) clearances naming this product code
Who Else Makes It
Concentrated in Fujian (4), Zhejiang (1), Guangdong (1). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Flexicare Medical (Dongguan) Ltd. | Dongguan | Guangdong | Contract manufacturer | 48 |
| GaleMed (Xiamen) Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 33 |
| Polymed (Xiamen) Plastic Industrial Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 17 |
| VR Medical Technology Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 13 |
| Ambu Limited | Xiang Yu F.T.Z., Xiamen | Fujian | Contract manufacturer | 11 |
| Huzhou Junda Industry Co., Ltd. | Anji | Zhejiang | Contract manufacturer | 129 |
| Laerdal Medical (Suzhou) Co., Ltd. | 215009 Suzhou Jiangsu Province | Repacker / relabeller | 12 | |
| Xiamen Compower Medical Tech. Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 9 |
Record
| Listed by | Ambu A/S, Denmark |
|---|---|
| FDA product code | BTM |
| Device type | Ventilator, Emergency, Manual (Resuscitator) |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5915 |
| Establishment | Specification developer, Private-label distributor, Manufacturer, Exporter |
| Record published | 2021-09-20 |
| 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, manufacturing date |
| Storage | Storage environment temperature -40 to 60 °C; Handling environment temperature -18 to 50 °C |
| Packaging | Pack of 12, pack of 6 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 530213048 | Pediatric | In distribution |
| 530213051 | Pediatric | In distribution |
| 530613051 | Pediatric | In distribution |
| 530213061 | Pediatric | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ventlab | Ventlab, LLC | 405 |
| CPR-2 Bag | Mercury Medical Enterprises, LLC | 231 |
| CPR Bag | Mercury Medical Enterprises, LLC | 187 |
| Vital Signs™ | Airlife, Inc. | 102 |
| Medline | Medline Industries, Inc. | 78 |
| Spur® II Pediatric ResuscitatorSingle Patient Use Resuscitator | Ambu A/S | 74 |
| Spur® II Adult ResuscitatorSingle Patient Use Resuscitator | Ambu A/S | 66 |
| Hudson RCI | Teleflex Medical LLC | 56 |
| Medline Industries, Inc. | Medline Industries, Inc. | 53 |
| Portex | ICU Medical, Inc | 45 |
| Spur® II Infant ResuscitatorSingle Patient Use Resuscitator | Ambu A/S | 45 |
| Curaplex® | Bound Tree Medical, LLC | 38 |
Showing 12 of 342. All products under Ventilator, Emergency, Manual (Resuscitator)
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K152931 | 2016-08-29 |
| K102824 | 2011-01-28 |
| K053140 | 2005-12-23 |
| K053142 | 2005-12-20 |
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.