Curaplex®
Curaplex Small Adult/Pediatric Premium BVM w/ Bag Reservoir, Manometer, 25cm Pop-off, Filter, Peep Valve & 2 Masks
8manufacturers in China registered for this device type
38catalogue numbers in this listing
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 | Bound Tree Medical, LLC, United States |
|---|---|
| FDA product code | BTM |
| Device type | Ventilator, Emergency, Manual (Resuscitator) |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5915 |
| Establishment | Manufacturer |
| 510(k) | K053466 |
| Record published | 2025-09-24 |
| Record revised | 2026-05-18 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature 59 to 86 °F; Special storage condition: Store at room temperature. Do not get wet. |
| Packaging | Case of 10, box of 10, case of 20, case of 12, pack of 12 |
| Sizes | Total volume 280 to 1500 ml |
| Distribution end date | 2026-05-01 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 8600-01550 | In distribution | |
| 2442-BVMPAD-ET | In distribution | |
| 30079 | In distribution | |
| 8600-01294 | In distribution | |
| 301-BVM300 | In distribution | |
| 30071 | In distribution | |
| 8600-01289 | In distribution | |
| AF2000 | In distribution | |
| 8600-01159 | In distribution | |
| 30070 | Total Volume 1500 ml | In distribution |
| AF5000 | In distribution | |
| 2442-BVMPSA-ET | In distribution | |
| 30070 | In distribution | |
| 301-BVM1000 | In distribution | |
| AF4000 | In distribution | |
| 8600-01511 | In distribution | |
| 30072MS | Total Volume 280 ml | In distribution |
| 8600-01442 | In distribution | |
| 30078 | In distribution | |
| 36101 | In distribution | |
| 670158-KIT | In distribution | |
| 30071 | Total Volume 450 ml | In distribution |
| 8600-01294 | In distribution | |
| 301-BVM550 | In distribution | |
| 2442-BVMCIN | In distribution | |
| 30072MS | In distribution | |
| 2442-BVMPAA | In distribution | |
| 2442-BVMPIC | In distribution | |
| 301-BVM1500 | In distribution | |
| 8600-01522 | In distribution | |
| AF3000 | In distribution | |
| 8600-01555 | In distribution | |
| 8600-01521 | In distribution | |
| 8600-ATFMLOK | In distribution | |
| 8600-01316 | In distribution | |
| 681250C | In distribution | |
| 670041-KIT | In distribution | |
| 8600-01555 | Withdrawn |
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 |
| Vital Signs | Carefusion | 31 |
Showing 12 of 342. All products under Ventilator, Emergency, Manual (Resuscitator)
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 |
|---|---|---|---|---|---|
| SunMed Group Holdings, LLC | UDI-DI | 2023-10-11 | Class II | Device Design | A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing. |
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.