Curaplex®
Curaplex CPAP Starter Kit incl CPAP Unit, Bag w/Strap, SM Mask, LG Mask, Breathing Circuit w/MED Mask
9manufacturers in China registered for this device type
31catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (5), Fujian (3), elsewhere (1). 7 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 |
| Sunmed AP, Ltd. | Zhuhai | Guangdong | Contract manufacturer | 18 |
| Polymed (Xiamen) Plastic Industrial Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 17 |
| Sunmed AP, Ltd., Warehouse NO. 2 | Zhuhai | Guangdong | Contract manufacturer | 16 |
| Ambu Limited | Xiang Yu F.T.Z., Xiamen | Fujian | Contract manufacturer | 11 |
| Flying Tooling Engineering Limited | Dongguan | Guangdong | Contract manufacturer | 9 |
| Laerdal Medical (Suzhou) Co., Ltd. | 215009 Suzhou Jiangsu Province | Repacker / relabeller | 12 | |
| Shenzhen Wellcore Well Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 2 |
Record
| Listed by | Bound Tree Medical, LLC, United States |
|---|---|
| FDA product code | BYE |
| Device type | Attachment, Breathing, Positive End Expiratory Pressure |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5965 |
| Establishment | Manufacturer |
| 510(k) | K053466 |
| Record published | 2025-07-09 |
| Record revised | 2022-08-16 (version 4) |
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 |
| Packaging | Case of 15, case of 10, box of 20, pack of 200, case of 50, case of 100 |
| Sizes | Circumference 20 to 30 mm |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SCPAPMD303-24-KIT | In distribution | |
| 670226-KIT | In distribution | |
| MRIPEEP-A | In distribution | |
| 8600-01297-DOD | In distribution | |
| SCPAPMD302-24-KIT | In distribution | |
| 670235-KIT | In distribution | |
| 670225-KIT | In distribution | |
| 30079 | Circumference 30 mm | In distribution |
| MRIPEEP | In distribution | |
| 670236-KIT | In distribution | |
| 677555 | In distribution | |
| 8600-01463 | In distribution | |
| 670217-KIT | In distribution | |
| 2525-31601 | In distribution | |
| 670214-KIT | In distribution | |
| 2430-19010 | In distribution | |
| 670213-KIT | In distribution | |
| 2430-26856 | In distribution | |
| 670216-KIT | In distribution | |
| 8600-01468 | In distribution | |
| SGOPAPMD02-24-KIT | In distribution | |
| 30078 | Circumference 20 mm | In distribution |
| 8600-01464 | In distribution | |
| 36797 | In distribution | |
| SGOPAPLG01-24-KIT | In distribution | |
| SGOPAPMD01-24-KIT | In distribution | |
| 670265-KIT | In distribution | |
| SCPAPMD301-24-KIT | In distribution | |
| 670170-KIT-DOD | In distribution | |
| 670215-KIT | In distribution | |
| 2430-26956 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| O2-MAX | Pulmodyne Inc. | 136 |
| 02-MAX | Pulmodyne Inc. | 83 |
| 02-RESQ | Pulmodyne Inc. | 43 |
| Flow-Safe II Disposable CPAP System | Mercury Medical Enterprises, LLC | 36 |
| AincA | Anesthesia Associates, Inc. | 30 |
| Flow-Safe Disposable CPAP System | Mercury Medical Enterprises, LLC | 29 |
| Attachment, Breathing, Positive End Expiratory Pressure | Galemed Corp. | 25 |
| Shiley | Covidien LP | 21 |
| Infant Resuscitation Kit. T-Piece Circuit | Flexicare Medical Ltd. | 20 |
| AirLife | Carefusion | 17 |
| O2-RESQ | Pulmodyne Inc. | 17 |
| Go-PAP | Pulmodyne Inc. | 14 |
Showing 12 of 139. All products under Attachment, Breathing, Positive End Expiratory Pressure
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.