Catalog Number

5030890

Brand Name

WarmTouch

Version/Model Number

5030890

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

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

K131361,K131361

Product Code

DWJ

Product Code Name

System, thermal regulating

Public Device Record Key

902f2ecf-f79a-49e2-ad4c-77331f87838d

Public Version Date

March 11, 2019

Public Version Number

1

DI Record Publish Date

February 06, 2019

Package DI Number

20884521141114

Quantity per Package

12

Contains DI Package

10884521141117

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE