Duns Number:055363428
Device Description: Intellisense Adult defibrillation Pads, non-polarized, with CPR Feedback Device for Powerh Intellisense Adult defibrillation Pads, non-polarized, with CPR Feedback Device for Powerheart® G5
Catalog Number
XELAED002A
Brand Name
Intellisense Adult Defibrillation Pads,CPR Device, Powerheart® G5
Version/Model Number
XELAED002A
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
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
LIX
Product Code Name
Aid, Cardiopulmonary Resuscitation
Public Device Record Key
a2554ebc-bc39-4cbd-b5d5-bc0d1a35a5e0
Public Version Date
February 08, 2022
Public Version Number
3
DI Record Publish Date
February 14, 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 |