Duns Number:961027315
Device Description: Monitoring Electrode, RT Snap, Cloth, Tear Drop
Catalog Number
E501CSTR
Brand Name
CARDINAL HEALTH
Version/Model Number
E501CSTR
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 29, 2021
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
c3d6061e-4670-4baf-abb9-a4051dcf35a1
Public Version Date
January 29, 2021
Public Version Number
6
DI Record Publish Date
August 17, 2016
Package DI Number
50885380074620
Quantity per Package
10
Contains DI Package
20885380074629
Package Discontinue Date
January 29, 2021
Package Status
Not 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 | 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 |