Duns Number:659276906
Device Description: Activox, Charger DC/DC
Catalog Number
-
Brand Name
Charger DC/DC
Version/Model Number
XYC104
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
-
Product Code
CAW
Product Code Name
Generator, Oxygen, Portable
Public Device Record Key
519a479e-f4de-4432-af5d-523b4e0e313d
Public Version Date
April 20, 2020
Public Version Number
2
DI Record Publish Date
August 01, 2018
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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 16 |