Catalog Number

-

Brand Name

Health Mate Forever

Version/Model Number

1

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

-

Prescription Use (Rx)

Yes

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

edecebeb-f048-4bc1-b2df-2b0f84c44df6

Public Version Date

October 05, 2020

Public Version Number

1

DI Record Publish Date

September 27, 2020

Package DI Number

16973602730020

Quantity per Package

160

Contains DI Package

06973602730023

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-