Catalog Number

-

Brand Name

Infrared Ear Thermometer

Version/Model Number

HTD8208C

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

K180387,K180387

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

0ac1268c-1e79-4369-9dfb-9afbcd3080ea

Public Version Date

April 28, 2021

Public Version Number

3

DI Record Publish Date

March 28, 2019

Package DI Number

16970289030061

Quantity per Package

40

Contains DI Package

06970289030064

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-