Catalog Number

-

Brand Name

Infrared Thermometer

Version/Model Number

PC816

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

K190717,K190717

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

eec4d1b6-a354-4cd3-af90-0206c7789554

Public Version Date

May 10, 2021

Public Version Number

1

DI Record Publish Date

May 01, 2021

Package DI Number

10840061481601

Quantity per Package

100

Contains DI Package

00840061481604

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-