Duns Number:836002451
Device Description: OX Series Inhalator valve, demand valve used with spontaneously breathing patients
Catalog Number
T25302-10
Brand Name
FERNO2 OX Inhalator
Version/Model Number
T25302-10
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
K963755
Product Code
CBP
Product Code Name
Valve, Non-Rebreathing
Public Device Record Key
30bc1276-8000-48ae-b004-50b0e888857d
Public Version Date
July 06, 2018
Public Version Number
3
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 |