Duns Number:013029698
Catalog Number
-
Brand Name
blood pressure monitor
Version/Model Number
MP-BPM80A-US
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
K120058,K120058,K120058
Product Code
DXN
Product Code Name
System, Measurement, Blood-Pressure, Non-Invasive
Public Device Record Key
e55a469b-93e7-491b-8b8f-7ef29ac495ea
Public Version Date
November 08, 2019
Public Version Number
4
DI Record Publish Date
November 18, 2016
Package DI Number
00817746020137
Quantity per Package
1
Contains DI Package
00817746020120
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. | 2 |