Duns Number:005036025
Device Description: Midmark EZ-trode disposable tab ECG electrodes are designed to provide excellent conductiv Midmark EZ-trode disposable tab ECG electrodes are designed to provide excellent conductivity and uniform current dispersion.
Catalog Number
2-100-0204
Brand Name
Disposable EZ-Trode ECG Electrodes
Version/Model Number
2-100-0204
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"
Yes
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
DPS
Product Code Name
Electrocardiograph
Public Device Record Key
3bc4eb9f-c387-4346-a6eb-f0893cfb528e
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 24, 2016
Package DI Number
30841709100216
Quantity per Package
10
Contains DI Package
20841709100219
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| 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 |