Duns Number:080935429
Device Description: 20660 Adult Multi-Function Defibrillation Electrodes, Radiotransparent
Catalog Number
20660
Brand Name
Kendall
Version/Model Number
20660
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
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
-
Product Code
DRO
Product Code Name
Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
Public Device Record Key
d10b9c7c-4b3d-47b2-8e99-bd0555a22caa
Public Version Date
October 12, 2020
Public Version Number
7
DI Record Publish Date
September 18, 2014
Package DI Number
10884527015597
Quantity per Package
5
Contains DI Package
20884527015594
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 | 672 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1692 |
| U | Unclassified | 17 |