Catalog Number

-

Brand Name

Easy@Home Infrared Ear Thermometers

Version/Model Number

EET-302

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K153146,K153146

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

37cdbc01-a2d9-45ae-837a-f210ebe1c778

Public Version Date

November 26, 2018

Public Version Number

3

DI Record Publish Date

August 01, 2016

Package DI Number

10850253007212

Quantity per Package

75

Contains DI Package

00850253007215

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-