Duns Number:137468570
Device Description: MOBI Health Wrist Blood Pressure Monitor (Sphygmomanometers)
Catalog Number
-
Brand Name
MOBI
Version/Model Number
70167
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 31, 2020
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
2c9a36c4-7a79-4ffc-8d67-87f61a3a0d76
Public Version Date
December 31, 2020
Public Version Number
6
DI Record Publish Date
September 07, 2017
Package DI Number
20891040701675
Quantity per Package
24
Contains DI Package
00891040701671
Package Discontinue Date
December 31, 2020
Package Status
Not in Commercial Distribution
Package Type
Cardboard
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 6 |