Catalog Number

-

Brand Name

Infrared Forehead Thermometer

Version/Model Number

5613

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K131243,K131243

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

4680e76a-5ba7-4ca6-aac4-bc8ad7d0f31c

Public Version Date

December 04, 2020

Public Version Number

4

DI Record Publish Date

September 24, 2016

Package DI Number

00616784561332

Quantity per Package

10

Contains DI Package

00616784561325

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-