Catalog Number

5030850

Brand Name

WarmTouch

Version/Model Number

5030850

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

K913016,K913016

Product Code

DWJ

Product Code Name

System, thermal regulating

Public Device Record Key

6a852b36-4c61-4a2a-a297-f5f064e20552

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

September 24, 2016

Package DI Number

10884521061514

Quantity per Package

12

Contains DI Package

20884521061511

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE