Duns Number:177667227
Catalog Number
-
Brand Name
Health Mart
Version/Model Number
BP3MR1-HHM
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
3d45a9f9-2dc5-4422-b31e-15f9dca4d9d5
Public Version Date
June 11, 2020
Public Version Number
4
DI Record Publish Date
January 06, 2017
Package DI Number
10052569136512
Quantity per Package
12
Contains DI Package
00052569136515
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
carton packing
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 25 |