Duns Number:079503890
Device Description: HeartStart Telemedicine System Upgrade
Catalog Number
861441
Brand Name
PHILIPS HeartStart Telemedicine System
Version/Model Number
861441
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
MSX
Product Code Name
System,Network And Communication,Physiological Monitors
Public Device Record Key
ab4445e8-3ac9-4b15-ba36-e1a873fe6127
Public Version Date
December 07, 2020
Public Version Number
4
DI Record Publish Date
September 24, 2015
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 |