Duns Number:836002451
Device Description: HFOC valve, refill valve for use with Bag Valve Mask resuscitator.
Catalog Number
T25301
Brand Name
FERNO2 HFOC
Version/Model Number
T25301
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K953349
Product Code
CBP
Product Code Name
Valve, Non-Rebreathing
Public Device Record Key
0e474fa1-e53f-4162-8d54-e42707c53c8d
Public Version Date
July 12, 2019
Public Version Number
4
DI Record Publish Date
November 09, 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 | 9 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 10 |