Catalog Number

FT45

Brand Name

FeverScan

Version/Model Number

1023B NDP

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"

Yes

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

KPD

Product Code Name

Strip, Temperature, Forehead, Liquid Crystal

Public Device Record Key

ff217c72-3349-4932-9c3e-155c96f9dbf7

Public Version Date

January 12, 2022

Public Version Number

1

DI Record Publish Date

January 04, 2022

Package DI Number

10815236021098

Quantity per Package

1

Contains DI Package

00815236021091

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Plastic Case