Duns Number:398037580
Device Description: moorVMS-PRES - Pressure Cuff Controller
Catalog Number
-
Brand Name
Moor Instruments Ltd
Version/Model Number
moorVMS-PRES
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
K102433
Product Code
DPW
Product Code Name
Flowmeter, Blood, Cardiovascular
Public Device Record Key
b066f539-ff33-48d5-9585-d1ee837cf7eb
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
July 08, 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 |