Duns Number:071595540
Device Description: V-TRACE ADULT RESTING TAB ECG ELECTRODE
Catalog Number
1935-100
Brand Name
V-TRACE
Version/Model Number
1935-100
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
K910494,K910494,K910494
Product Code
DRX
Product Code Name
Electrode, electrocardiograph
Public Device Record Key
81fd1b04-4b16-4439-b7b3-b82e2d4e55f1
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 24, 2016
Package DI Number
20653405057342
Quantity per Package
4000
Contains DI Package
10653405057345
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BOX
| 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 |