Duns Number:225232610
Device Description: A stationary probe directs a continuous 4MHz beam of ultrasound waves at blood flowing in A stationary probe directs a continuous 4MHz beam of ultrasound waves at blood flowing in the descending aorta. The shift in the frequency of the reflected ultrasound waves caused by the moving blood cells are translated by the CardioQ™ into a real time display of the velocity of the blood against time. Analysis of the waveform provides information on a range of cardiac parameters to be derived.
Catalog Number
-
Brand Name
I2C72 Doppler Probe
Version/Model Number
9090-7017
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
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K073593,K073593,K073593,K073593,K073593
Product Code
DPT
Product Code Name
Probe, Blood-Flow, Extravascular
Public Device Record Key
618783ba-589e-421d-bfaf-860b536f8932
Public Version Date
April 07, 2021
Public Version Number
4
DI Record Publish Date
September 07, 2016
Package DI Number
5055679401943
Quantity per Package
5
Contains DI Package
05055679400090
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Kraft Cardboard
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |