Duns Number:190713797
Device Description: G3Plus, AED, Automatic ,AHA 2010, with adult pads and battery
Catalog Number
9390A-1001
Brand Name
Powerheart® AED G3 Plus Automatic AED
Version/Model Number
9390A-1001
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
-
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
Product Code
MKJ
Product Code Name
Automated External Defibrillators (Non-Wearable)
Public Device Record Key
97f296f7-dfe6-4ccf-ac83-7f7c77b88d9d
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
September 29, 2014
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |
| 3 | A medical device with high risk that requires premarket approval | 54 |