Duns Number:225232610
Device Description: The CardioQ-EDM+ monitor in HD-ICG mode is intended for use by medically qualified personn The CardioQ-EDM+ monitor in HD-ICG mode is intended for use by medically qualified personnel to evaluate and guide optimization of hemodynamic performance in anesthetized, sedated or conscious patients; and is intended for use in the operating room, intensive care unit, emergency room, obstetrics department or other wards or departments where hemodynamic measurement is required. HD-ICG Electrode Convenience Kits contains 2 packs of 3 electrodes and a RFID smart card in a labelled clear plastic bag. The Kits are sold in a labelled shelf box which contains 5 Convenience kits.
Catalog Number
7057-7005
Brand Name
HD-ICG Electrode Convenience Kits
Version/Model Number
7057-7005
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
DRX
Product Code Name
Electrode, Electrocardiograph
Public Device Record Key
25ca520b-da0b-4cdb-8121-2a195904e0a1
Public Version Date
March 11, 2019
Public Version Number
1
DI Record Publish Date
February 22, 2019
Package DI Number
05055679404623
Quantity per Package
20
Contains DI Package
05055679404616
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 |