Duns Number:055363428
Device Description: Powerheart® G3 Elite AED, Fully Automatic, Korean, with Adult Pads and Battery
Catalog Number
9790A-1019
Brand Name
Powerheart G3 Elite Automatic AED Kit
Version/Model Number
9790A-1019
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
-
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
P160033
Product Code
MKJ
Product Code Name
Automated External Defibrillators (Non-Wearable)
Public Device Record Key
3273b635-f2be-45d3-b5a4-7158abca1d99
Public Version Date
February 08, 2022
Public Version Number
2
DI Record Publish Date
July 01, 2020
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 |