Duns Number:055363428
Device Description: IntelliSense lithium battery (yellow): For Powerheart AED G3 model 9300 A/E and 9390 A/E s IntelliSense lithium battery (yellow): For Powerheart AED G3 model 9300 A/E and 9390 A/E shipped after April 12, 2004 with 4 year full replacement guarantee.
Catalog Number
9146-302
Brand Name
Powerheart® G3 Battery
Version/Model Number
9146-302
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,K102496
Product Code
MKJ
Product Code Name
Automated External Defibrillators (Non-Wearable)
Public Device Record Key
f2ecf425-11f4-488e-9fbb-d6deef878b6b
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 |