Catalog Number

140008

Brand Name

Exergen Temporal Scanner

Version/Model Number

TAT2000C

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

f0c5879d-ef9a-4fca-9b08-662525a25acb

Public Version Date

March 03, 2022

Public Version Number

5

DI Record Publish Date

September 24, 2016

Package DI Number

10834098002069

Quantity per Package

3

Contains DI Package

00834098002062

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box