Catalog Number

-

Brand Name

Medical Fitness Research

Version/Model Number

ET-100B

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 30, 2019

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

474a562f-ee72-4d1c-8e10-a055e00a760a

Public Version Date

July 23, 2020

Public Version Number

3

DI Record Publish Date

April 11, 2017

Package DI Number

10862835000306

Quantity per Package

100

Contains DI Package

00862835000309

Package Discontinue Date

December 30, 2019

Package Status

Not in Commercial Distribution

Package Type

-