Duns Number:225232610
Device Description: The CardioQ EDM is intended for use as a fluid management and cardiac output monitoring s The CardioQ EDM is intended for use as a fluid management and cardiac output monitoring system. The system is designed to provide clinicians with real-time information about left-ventricular blood flow.
Catalog Number
-
Brand Name
Deltex Medical CardioQ EDM
Version/Model Number
9051-7057
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
K111542,K111542
Product Code
DPW
Product Code Name
Flowmeter, Blood, Cardiovascular
Public Device Record Key
c4c9bc8b-e902-499b-ac12-411b309da2ca
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 07, 2016
Package DI Number
5055679406108
Quantity per Package
1
Contains DI Package
05055679404319
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Cardboard Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |