Duns Number:116956644
Catalog Number
-
Brand Name
HealthMart
Version/Model Number
BP3NM1-3WHM
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
ef3f83bc-1f82-4e78-be4e-55dd8b8c8db2
Public Version Date
August 27, 2020
Public Version Number
2
DI Record Publish Date
July 31, 2020
Package DI Number
10052569143749
Quantity per Package
6
Contains DI Package
00052569143742
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. | 12 |