Catalog Number

005-00044

Brand Name

Aegis Infrared Thermometer

Version/Model Number

LX-26E

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

K160816

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

8529aa43-4229-4584-85bf-cff57508d9ee

Public Version Date

December 04, 2020

Public Version Number

2

DI Record Publish Date

April 20, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-