Duns Number:071595540
Device Description: Totaltrace Adult General Purpose Foam ECG Electrode
Catalog Number
3700C-005
Brand Name
TOTALTRACE
Version/Model Number
3700C-005
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Safe
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
89566400-f12d-4c3e-b648-3b231b49b175
Public Version Date
February 06, 2020
Public Version Number
1
DI Record Publish Date
January 29, 2020
Package DI Number
30845854051256
Quantity per Package
600
Contains DI Package
10845854051252
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 | 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 |