Catalog Number

-

Brand Name

Infrared Thermometer

Version/Model Number

PC868

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

K172889,K172889

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

1564bc71-e12f-4a87-8e57-fba6f3c65ec0

Public Version Date

December 04, 2020

Public Version Number

2

DI Record Publish Date

April 15, 2020

Package DI Number

10840061486804

Quantity per Package

72

Contains DI Package

00840061486807

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-