Duns Number:324416379
Device Description: MRI ECG Electrode 70mm x 70mm
Catalog Number
5300202
Brand Name
ezPad MRI
Version/Model Number
small
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
MR Conditional
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
b135e8c3-bee0-4fd7-af5f-7c7d45ae7b29
Public Version Date
April 17, 2020
Public Version Number
2
DI Record Publish Date
October 23, 2018
Package DI Number
EMIP53002021
Quantity per Package
25
Contains DI Package
EMIP53002020
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 39 |