O_two CPAP
o_two CPAP is an oxygen-flow-driven system for maintaining positive airway pressure in a spontaneously breathing patient. Its open circuit has no moving parts and uses a vectored-flow…
o_two CPAP is an oxygen-flow-driven system for maintaining positive airway pressure in a spontaneously breathing patient. Its open circuit has no moving parts and uses a vectored-flow valve.
The valve creates resistance during expiration while adding flow during inspiration. Adjusting the oxygen supply flow raises or lowers the baseline airway pressure.
Listed Item
The O-Two single-use open CPAP delivery system provides 5-20 cmH2O CPAP pressure to patients. The adjustment of the CPAP level is achieved by adjusting the output flow from oxygen therapy regulator or wall outlet. The setting selections noted on the device provide an accurate constant airway pressure at each flow setting.
Respiratory Support Configuration
The system is intended for adult and pediatric patients requiring respiratory support in hospital or emergency medical-service settings. The oxygen source supplies the operating flow; the valve generates CPAP without a motor-driven blower in the patient circuit.
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 | O-TWO Medical Technologies, Inc., Canada |
|---|---|
| FDA product code | BYE |
| Device type | Attachment, Breathing, Positive End Expiratory Pressure |
| Device class | Class 2 |
| Regulation | 21 CFR 868.5965 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K112546 |
| Record published | 2015-10-24 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature -40 to 60 °C |
| Packaging | Carton of 10, carton of 50, cafrton of 10 |
| Sizes | Weight 0.1 kg; length 2.3 in; outer diameter 1.6 in |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 01CV0228 | Weight 0.1 kg | In distribution |
| 01CV0213 | Weight 0.1 kg | In distribution |
| 01CV0211 | Weight 0.1 kg | In distribution |
| 01CV0222 | Weight 0.1 kg | In distribution |
| 01CV0219 | Weight 0.1 kg | In distribution |
| 01CV0212 | Weight 0.1 kg | In distribution |
| 01CV0218 | Weight 0.1 kg | In distribution |
| 01CV0210 | Length 2.3 in | In distribution |
| 01CV0227 | Weight 0.1 kg | In distribution |
| 01CV0221 | Weight 0.1 kg | In distribution |
| 01CV0229 | Weight 0.1 kg | In distribution |
| 01CV0223 | Weight 0.1 kg | In distribution |
| 01CV0217 | Weight 0.1 kg | 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 |
| Curaplex® | Bound Tree Medical, LLC | 31 |
| 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 |
Showing 12 of 139. All products under Attachment, Breathing, Positive End Expiratory Pressure
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K112546 | 2011-12-27 |
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.