Duns Number:005036025
Device Description: Midmark IQvitals® is an affordable, Windows® based device that provides automated blood pr Midmark IQvitals® is an affordable, Windows® based device that provides automated blood pressure, temperature, SpO2 and pulse rate readings with a touch of the screen.
Catalog Number
1-100-1615
Brand Name
Midmark IQvitals® Device with touchscreen - Blood Pressure, Temperature and SpO
Version/Model Number
1-100-1615
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)
Yes
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
5e89c664-0dc8-4bca-98dc-c69cfacd324f
Public Version Date
November 10, 2021
Public Version Number
5
DI Record Publish Date
September 24, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 838 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 544 |