Duns Number:545348500
Catalog Number
-
Brand Name
Wrist Blood Pressure Monitor
Version/Model Number
JB8149WHI
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
DXN
Product Code Name
System, Measurement, Blood-Pressure, Non-Invasive
Public Device Record Key
88bffab9-bb4f-4786-a690-a2507a6fe87e
Public Version Date
November 08, 2019
Public Version Number
2
DI Record Publish Date
March 23, 2018
Package DI Number
06944249302201
Quantity per Package
24
Contains DI Package
06944249302195
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. | 20 |