Catalog Number

ET-5454

Brand Name

iReliev

Version/Model Number

ET-5454

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)

Yes

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

GXY

Product Code Name

Electrode, Cutaneous

Public Device Record Key

55c2b347-2103-433f-8119-a0ea8a55fe31

Public Version Date

February 19, 2021

Public Version Number

5

DI Record Publish Date

January 12, 2018

Package DI Number

20853635002451

Quantity per Package

40

Contains DI Package

00853635002457

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton