Duns Number:961027315
Device Description: Monitoring Electrode, RT Snap, Foam, Tear Drop
Catalog Number
E301FSTR
Brand Name
CARDINAL HEALTH
Version/Model Number
E301FSTR
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
K020003,K020003,K020003,K020003
Product Code
DRX
Product Code Name
Electrode, electrocardiograph
Public Device Record Key
4b7223cd-0436-4012-af62-1839f74640cd
Public Version Date
July 20, 2018
Public Version Number
4
DI Record Publish Date
August 17, 2016
Package DI Number
20885380074636
Quantity per Package
20
Contains DI Package
30885380074633
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 | 101686 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 139430 |
| 3 | A medical device with high risk that requires premarket approval | 8 |
| U | Unclassified | 40 |