Duns Number:961027315
Device Description: Electrode, ECG, Monitoring, SS Snap, Foa
Catalog Number
E501FATM
Brand Name
CARDINAL HEALTH
Version/Model Number
E501FATM
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
July 01, 2019
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
K041954,K041954,K041954,K041954
Product Code
DRX
Product Code Name
Electrode, electrocardiograph
Public Device Record Key
3ef81da0-91dc-4a53-98d2-6461aa5bca53
Public Version Date
July 01, 2019
Public Version Number
6
DI Record Publish Date
September 01, 2016
Package DI Number
20885380047746
Quantity per Package
100
Contains DI Package
30885380047743
Package Discontinue Date
July 01, 2019
Package Status
Not 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 |