Duns Number:079503890
Device Description: Heartstream Pads to Zoll Adapter
Catalog Number
-
Brand Name
PHILIPS HeartStart Pads Adapter for Zoll defibrillators
Version/Model Number
05-10100
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
-
Product Code
MKJ
Product Code Name
Automated External Defibrillators (Non-Wearable)
Public Device Record Key
9e054298-abce-46af-b8b1-8f1343e320da
Public Version Date
December 07, 2020
Public Version Number
4
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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 14 |
3 | A medical device with high risk that requires premarket approval | 53 |