Catalog Number

315710REG

Brand Name

Regard™

Version/Model Number

T100AC

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

MLN

Product Code Name

Electrode, Electrodcardiograph, Multi-Function

Public Device Record Key

26e5358b-5f2b-4cca-bf2c-2aac74a1421a

Public Version Date

September 02, 2020

Public Version Number

3

DI Record Publish Date

March 24, 2017

Package DI Number

10326053105484

Quantity per Package

10

Contains DI Package

00326053105487

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-