Duns Number:611739603
Device Description: Adult electrodes for use with Cardiac Science(TM) AEDs - Can be used in place of Cardiac S Adult electrodes for use with Cardiac Science(TM) AEDs - Can be used in place of Cardiac Science(TM) electrodes part number 9131-001
Catalog Number
-
Brand Name
AED Brands, LLC
Version/Model Number
AB 9131-001
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
K131494,K131494
Product Code
MKJ
Product Code Name
Automated External Defibrillators (Non-Wearable)
Public Device Record Key
7de71f0a-e51c-4c27-8e7d-5582ad4d2827
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
February 11, 2015
Package DI Number
90865292000113
Quantity per Package
10
Contains DI Package
90865292000106
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 3 | A medical device with high risk that requires premarket approval | 2 |