Duns Number:489470686
Device Description: Finger cuff size Medium NC
Catalog Number
FP_400223
Brand Name
Finapres
Version/Model Number
Finger cuff size Medium 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
-
Product Code
DSB
Product Code Name
Plethysmograph, Impedance
Public Device Record Key
58e7b31e-a16f-4d87-81b6-d6919c82c5bb
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 |