Duns Number:656103819
Device Description: BP-801 is the device for the measurement of blood pressure & pulse rate of patient.
Catalog Number
-
Brand Name
NOKIA
Version/Model Number
BP-801
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)
Yes
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
DXN
Product Code Name
System, Measurement, Blood-Pressure, Non-Invasive
Public Device Record Key
7d239a4b-610a-4304-b2db-d4f0b2ff88d1
Public Version Date
November 08, 2019
Public Version Number
3
DI Record Publish Date
June 03, 2017
Package DI Number
14719873310057
Quantity per Package
10
Contains DI Package
04719873310050
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 4 |