Duns Number:039840984
Device Description: Lithium - Sulfur Dioxide battery for replacement in Cardiac Science(TM) Powerheart(TM) 920 Lithium - Sulfur Dioxide battery for replacement in Cardiac Science(TM) Powerheart(TM) 9200RD, 9210RD AT, and Survivalink Firstsave(TM) 9100, 9110, 9200, 9210, 9200D, and 9210D
Catalog Number
9141-ABE
Brand Name
AED Battery Exchange
Version/Model Number
9141-ABE
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K120350
Product Code
MKJ
Product Code Name
Automated External Defibrillators (Non-Wearable)
Public Device Record Key
2634a35c-f0da-4924-af91-4de8bdbdbc15
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
March 08, 2016
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 |
|---|---|---|
| 3 | A medical device with high risk that requires premarket approval | 9 |