Catalog Number

40068

Brand Name

3M™

Version/Model Number

40068

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

K060865,K060865

Product Code

DWJ

Product Code Name

System, thermal regulating

Public Device Record Key

49a21679-f6bd-4b15-bd64-263c50d889bb

Public Version Date

August 24, 2018

Public Version Number

1

DI Record Publish Date

July 24, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-