Duns Number:055363428
Device Description: RT430 ECG SMALL 1.5" ROUND ELECTRODES, 6 STRIPS OF 5 PER POUCH
Catalog Number
-
Brand Name
ECG
Version/Model Number
9600-0704
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"
-
For Single-Use
-
Prescription Use (Rx)
-
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
9cf56216-fdf2-46f3-9fad-2aad5d012ac9
Public Version Date
February 08, 2022
Public Version Number
3
DI Record Publish Date
August 03, 2016
Package DI Number
10847946021051
Quantity per Package
10
Contains DI Package
00847946021054
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 | 10 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1473 |
| 3 | A medical device with high risk that requires premarket approval | 1032 |