Catalog Number

-

Brand Name

FUKUDA DENSHI

Version/Model Number

TEY-162DX3-0.7A

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

-

Product Code

DRX

Product Code Name

Electrode, Electrocardiograph

Public Device Record Key

520428c0-b563-487e-b6af-c3c0300683cc

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

June 22, 2017

Package DI Number

44538612914025

Quantity per Package

20

Contains DI Package

24538612914021

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-