Duns Number:027183008
Device Description: Arctic Sun® Temperature Management System, Temperature Out Cable Philips
Catalog Number
73556
Brand Name
Arctic Sun® Temperature Management System, Temperature Out Cable Philips
Version/Model Number
73556
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
DWJ
Product Code Name
System, thermal regulating
Public Device Record Key
b98c176e-89e2-4790-a81a-0b33dded77d3
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 11, 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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 44 |