Duns Number:055363428
Device Description: Polarized Defibrillation Pads(adult) with two-year shelf life
Catalog Number
9660-001
Brand Name
Powerheart® Polarized Adult Defibrillation Pads
Version/Model Number
9660-001
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
K102496,K102496
Product Code
MKJ
Product Code Name
Automated External Defibrillators (Non-Wearable)
Public Device Record Key
10ceaa67-f287-4469-a571-3de20599cd9d
Public Version Date
February 08, 2022
Public Version Number
4
DI Record Publish Date
February 10, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 10 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1473 |
| 3 | A medical device with high risk that requires premarket approval | 1032 |