Duns Number:071595540
Device Description: Totaltrace Adult General Purpose Foam ECG Electrode
Catalog Number
3700-001
Brand Name
TOTALTRACE
Version/Model Number
3700-001
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 04, 2022
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
5371ab41-014b-4c1d-b39a-f53b59d96759
Public Version Date
June 06, 2022
Public Version Number
2
DI Record Publish Date
January 29, 2020
Package DI Number
30845854051201
Quantity per Package
600
Contains DI Package
10845854051207
Package Discontinue Date
June 04, 2022
Package Status
Not 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 | 1412 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2261 |
| 3 | A medical device with high risk that requires premarket approval | 95 |