Duns Number:049529118
Catalog Number
-
Brand Name
C6 Monitor A10e, Verizon
Version/Model Number
02-01804
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"
-
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
DSI
Product Code Name
Detector And Alarm, Arrhythmia
Public Device Record Key
aaaf3fc6-14bc-4826-a9e1-e292d07599e4
Public Version Date
March 29, 2022
Public Version Number
1
DI Record Publish Date
March 21, 2022
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. | 122 |