Catalog Number

Dual Scale

Brand Name

FeverScan

Version/Model Number

1003A

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

d5b993a0-8caa-4205-a4fe-76bdd85f9c68

Public Version Date

February 24, 2020

Public Version Number

3

DI Record Publish Date

June 14, 2018

Package DI Number

30815236020965

Quantity per Package

1

Contains DI Package

00815236020964

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Plastic Case