Duns Number:206449154
Device Description: The handheld CAREvent® CPAP provides CPAP delivery in a simple, compact device that can f The handheld CAREvent® CPAP provides CPAP delivery in a simple, compact device that can fit easily into existing oxygen kit. The ease-of-use design concept and unique single-use patient circuit with facemask, head harness and airway pressure gauge make application and operation of the O-Two CAREvent CPAP extremely simple for the rescuer and more comfortable and less distressing for the patient.
Catalog Number
01CV0200
Brand Name
CARevent CPAP
Version/Model Number
01CV0200-1
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
-
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
K093862,K093862
Product Code
BTL
Product Code Name
Ventilator, Emergency, Powered (Resuscitator)
Public Device Record Key
e66dfc02-4d97-4811-b8bd-7b7e62154e20
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
February 03, 2016
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 |