Duns Number:961027315
Device Description: Monitoring Electrode, Neonatal, Prewired, Cloth
Catalog Number
EPP3CL
Brand Name
CARDINAL HEALTH
Version/Model Number
EPP3CL
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
K053011,K053011,K053011
Product Code
DRX
Product Code Name
Electrode, electrocardiograph
Public Device Record Key
1aa72b1b-cebd-4806-8815-11241bbe1ef9
Public Version Date
July 20, 2018
Public Version Number
4
DI Record Publish Date
August 17, 2016
Package DI Number
50885380048461
Quantity per Package
10
Contains DI Package
20885380048460
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 | 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 |