Catalog Number

395100

Brand Name

CVS Health

Version/Model Number

MEP300R

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

January 01, 2020

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

IRT

Product Code Name

Pad, Heating, Powered

Public Device Record Key

0444431e-c929-47a6-9ba8-ed3313f3072e

Public Version Date

July 07, 2020

Public Version Number

3

DI Record Publish Date

November 22, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-