Duns Number:005036025
Device Description: Midmark IQvitals is an affordable, Windows based device that provides automated blood pres 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. Kit includes: IQvitals Device w/Blood Pressure, Temperature and SpO2, AC Power Supply, Reusable Blood Pressure Cuff - Adult, Reusable Blood Pressure Cuff - Large Adult, Blood Pressure Hose - 6.5', Reusable SpO2 Adult Finger Sensor, SpO2 Extender Cable - 4', Oral/Axillary Temperature Probe, Temperature Probe Covers (box of 20), Serial Cable - 10', and USB Cable - 10'.
Catalog Number
4-000-0510
Brand Name
Midmark IQvitals Device Kit w/touchscreen - Blood Pressure, Temperature and SpO2
Version/Model Number
4-000-0510
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
9b0a2ba7-4036-4be2-8b9d-12312dfeba51
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 |