Catalog Number

-

Brand Name

Forehead and Ear Thermometer

Version/Model Number

GM-400EF

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)

-

Over the Counter (OTC)

-

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

e5f52a7e-8a30-4bfd-9bf5-e16c45e1f8e2

Public Version Date

December 04, 2020

Public Version Number

3

DI Record Publish Date

September 28, 2016

Package DI Number

09351337000067

Quantity per Package

50

Contains DI Package

09351337000043

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-