Catalog Number

-

Brand Name

CVS Health

Version/Model Number

459917

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K132998,K132998,K132998,K132998

Product Code

GXY

Product Code Name

Electrode, Cutaneous

Public Device Record Key

5267e950-5f10-4c2f-9235-dca73e46145a

Public Version Date

February 19, 2021

Public Version Number

2

DI Record Publish Date

January 07, 2019

Package DI Number

20050428411104

Quantity per Package

30

Contains DI Package

10050428411107

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case Pack