Curaplex
*Custom* Guilford Adult BVM with Timing Light kit
3manufacturers in China registered for this device type
3catalogue 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 | Bound Tree Medical, LLC, United States |
|---|---|
| FDA product code | OEV |
| Device type | Cardiopulmonary Resuscitation Aid Kit |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5915 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2021-09-30 |
| Record revised | 2024-04-03 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 10, case of 25 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 8600-01487 | In distribution | |
| 8600-01148 | In distribution | |
| 8600-01147 | 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 |
| 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.