Catalog Number

140050, 144060, 140033

Brand Name

Exergen Temporal Scanner

Version/Model Number

TAT2000C Original

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

K011291,K011291

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

9e497dcb-83f3-446d-93cf-7ab680d35f4f

Public Version Date

December 04, 2020

Public Version Number

4

DI Record Publish Date

September 24, 2016

Package DI Number

10834098002915

Quantity per Package

6

Contains DI Package

00834098002918

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box