Duns Number:829221139
Device Description: Web application
Catalog Number
-
Brand Name
BioStamp nPoint™
Version/Model Number
SW-0028
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 01, 2021
Issuing Agency
In HIBCC
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"
Yes
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
-
Product Code
DRG
Product Code Name
Transmitters And Receivers, Physiological Signal, Radiofrequency
Public Device Record Key
d34d3cf6-9c1a-43ed-bd8a-4c7c0151dfa7
Public Version Date
April 02, 2021
Public Version Number
4
DI Record Publish Date
August 31, 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. | 28 |