Catalog Number

P431-100

Brand Name

FeverScan

Version/Model Number

P431

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

Yes

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

00e6c546-e67e-4a50-9053-81f1790b1d52

Public Version Date

February 24, 2020

Public Version Number

3

DI Record Publish Date

September 23, 2016

Package DI Number

20815236020425

Quantity per Package

500

Contains DI Package

10815236020428

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box