Duns Number:002111896
Catalog Number
6503178V
Brand Name
Equipment Evolutions
Version/Model Number
EEV10005-3-7%
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
DRX
Product Code Name
Electrode, Electrocardiograph
Public Device Record Key
5ff3080b-4017-4a6f-8451-d33cbe9eb05b
Public Version Date
August 05, 2019
Public Version Number
1
DI Record Publish Date
July 26, 2019
Package DI Number
50009336009393
Quantity per Package
600
Contains DI Package
10009336009395
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 161 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 269 |
| 3 | A medical device with high risk that requires premarket approval | 1 |