Duns Number:830437997
Device Description: Slim Design Wrist Digital BP Monitor
Catalog Number
-
Brand Name
VERIDIAN
Version/Model Number
01-511
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
K142088,K142088,K142088
Product Code
DXN
Product Code Name
System, Measurement, Blood-Pressure, Non-Invasive
Public Device Record Key
34991f4e-4b20-40da-9a47-8c8a7e467fd3
Public Version Date
November 08, 2019
Public Version Number
4
DI Record Publish Date
September 26, 2016
Package DI Number
30845717006485
Quantity per Package
3
Contains DI Package
00845717006484
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
INNER CARTON
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 127 |