Duns Number:827419834
Device Description: CardeaScreen is a portable ECG recorder designed for collection of resting (non-ambulatory CardeaScreen is a portable ECG recorder designed for collection of resting (non-ambulatory) ECG data with software used for subsequent analysis of the patient's ECG data.
Catalog Number
CS-2020-A
Brand Name
CardeaScreen
Version/Model Number
CS-2020-A
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
K123217
Product Code
DPS
Product Code Name
Electrocardiograph
Public Device Record Key
8728783c-20cd-423a-be62-03807f71253a
Public Version Date
March 10, 2021
Public Version Number
6
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |