Catalog Number

-

Brand Name

FeverScan Ultra

Version/Model Number

1026B1

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

44981e6f-90d6-413e-bfc0-9f001f52547e

Public Version Date

February 24, 2020

Public Version Number

4

DI Record Publish Date

May 09, 2017

Package DI Number

10815236020916

Quantity per Package

1

Contains DI Package

00815236020919

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

1CTN