Catalog Number

-

Brand Name

Easy@Home Non-contact Infrared Thermometer

Version/Model Number

JXB-178

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

5cb1a61e-5407-4455-8d8f-8f9855ddb4d8

Public Version Date

December 04, 2020

Public Version Number

2

DI Record Publish Date

August 28, 2020

Package DI Number

10810038630806

Quantity per Package

50

Contains DI Package

00810038630809

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-