Arctic Sun® Temperature Management System, Temperature Out Cable Philips - Arctic Sun® Temperature Management System, - Medivance, Inc.

Duns Number:027183008

Device Description: Arctic Sun® Temperature Management System, Temperature Out Cable Philips

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More Product Details

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

Product Characteristics

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 Details

Product Code

DWJ

Product Code Name

System, thermal regulating

Device Record Status

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

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"MEDIVANCE, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 44