Catalog Number

-

Brand Name

Infrared Thermometer

Version/Model Number

HT-104

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

K202440

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

43ff89a1-6932-4c2a-81ab-2e3450458547

Public Version Date

July 27, 2021

Public Version Number

1

DI Record Publish Date

July 19, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-