Duns Number:398037580
Device Description: Clinical software for micro vascular assessments in physiological research and clinical ap Clinical software for micro vascular assessments in physiological research and clinical applications.
Catalog Number
-
Brand Name
moorVMS-VASC PC Software
Version/Model Number
2
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K083082,K102433
Product Code
DPW
Product Code Name
Flowmeter, Blood, Cardiovascular
Public Device Record Key
4fe92ca6-fd4b-4531-a7de-048ee6f6c18f
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
November 24, 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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 17 |