Duns Number:053146767
Device Description: This reusable exhalation valve is designed for use with ventilators. The exhalation valve This reusable exhalation valve is designed for use with ventilators. The exhalation valve prevents the inspired gases from escaping through the passage that will be made available to expired gases via an inflatable balloon. Also, the re-breathing of the expired gases are prevented by the balloon action.
Catalog Number
-
Brand Name
BE 30-115-B Exhalation Valve
Version/Model Number
BE 30-115-B
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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"
Yes
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
K980725
Product Code
CBP
Product Code Name
Valve, Non-Rebreathing
Public Device Record Key
1286d0a7-098d-4f45-b360-04d394d41992
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
February 11, 2017
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 | 229 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 71 |