Catalog Number

-

Brand Name

Easy@Home Non-contact Infrared Thermometer

Version/Model Number

NCT-301

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

K130231,K130231

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

e704742e-43f9-4708-8cf3-6b7bc64aa3b2

Public Version Date

December 04, 2020

Public Version Number

4

DI Record Publish Date

August 05, 2016

Package DI Number

10850253007151

Quantity per Package

40

Contains DI Package

00850253007154

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-