Duns Number:830016148
Device Description: Nova Plus® Foam Monitoring Electrode V2228-3, 3/BAG, 200/CASE, 54/PLT
Catalog Number
V2228-3
Brand Name
Nova Plus®
Version/Model Number
V2228-3
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
81f91fbf-420c-4409-9c52-0703376fed2f
Public Version Date
May 16, 2019
Public Version Number
1
DI Record Publish Date
May 08, 2019
Package DI Number
50707387787627
Quantity per Package
200
Contains DI Package
10707387787629
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 | 274 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 444 |
| U | Unclassified | 7 |