Catalog Number

-

Brand Name

Infrared Thermometer

Version/Model Number

PC829

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

3dbf6677-5eea-4ea1-8200-534ea5c4b8a4

Public Version Date

April 26, 2021

Public Version Number

1

DI Record Publish Date

April 17, 2021

Package DI Number

10840061482905

Quantity per Package

50

Contains DI Package

00840061482908

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-