Duns Number:830437997
Device Description: Semi-Automatic Digital Blood Pressure Arm Monitor, Adult
Catalog Number
01-5041
Brand Name
VERIDIAN
Version/Model Number
01-5041
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
Yes
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
DXN
Product Code Name
System, Measurement, Blood-Pressure, Non-Invasive
Public Device Record Key
1cbd6a9d-9cf2-4855-856b-3a0ab8b09104
Public Version Date
November 08, 2019
Public Version Number
3
DI Record Publish Date
September 24, 2016
Package DI Number
30845717002692
Quantity per Package
3
Contains DI Package
00845717002691
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
INTERMEDIATE
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 127 |