Duns Number:230479318
Device Description: Combined Battery and Electrode Cartridge. Accessory to a therapeutic medical device in th Combined Battery and Electrode Cartridge. Accessory to a therapeutic medical device in the range of Automated External Defibrillators.
Catalog Number
Pad-Pak-01
Brand Name
Pad-Pak
Version/Model Number
Pad-Pak-01
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
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
-
Product Code
MKJ
Product Code Name
Automated External Defibrillators (Non-Wearable)
Public Device Record Key
4fdf9e7b-3182-43f8-9940-a5e6a40b3670
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 24, 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 |
---|---|---|
3 | A medical device with high risk that requires premarket approval | 28 |