Duns Number:206449154
Device Description: The O-Two single-use open CPAP delivery system provides 5-20 cmH2O CPAP pressure to patie 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.
Catalog Number
01CV0227-CS
Brand Name
o_two CPAP
Version/Model Number
01CV0227
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K112546
Product Code
BYE
Product Code Name
Attachment, Breathing, Positive End Expiratory Pressure
Public Device Record Key
a843a4cb-c094-4e8b-8b92-9dd29827bdd9
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 24, 2015
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 32 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 48 |
| U | Unclassified | 3 |