Duns Number:489470686
Device Description: Finapres NOVA Main Unit NC
Catalog Number
FP_910804
Brand Name
Finapres
Version/Model Number
Finapres NOVA Main Unit NC
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
K173916
Product Code
DQA
Product Code Name
Oximeter
Public Device Record Key
de82daae-8433-48be-9582-c4c74d97164d
Public Version Date
December 31, 2018
Public Version Number
1
DI Record Publish Date
November 30, 2018
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. | 33 |