Duns Number:176387785
Catalog Number
-
Brand Name
Microlife
Version/Model Number
BP3GX1-5A
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"
Yes
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
DXN
Product Code Name
System, Measurement, Blood-Pressure, Non-Invasive
Public Device Record Key
236b8f3b-eb42-4e85-b8e8-b73fd6cb0e4d
Public Version Date
November 08, 2019
Public Version Number
3
DI Record Publish Date
November 07, 2016
Package DI Number
20642632393514
Quantity per Package
6
Contains DI Package
10642632393517
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton box
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 27 |