Catalog Number

P436

Brand Name

FeverScan Mini Disposable

Version/Model Number

1104

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

c7ff0c61-9eb7-4c94-9c64-59d5fa8eb1cf

Public Version Date

November 03, 2020

Public Version Number

1

DI Record Publish Date

October 26, 2020

Package DI Number

10815236021043

Quantity per Package

100

Contains DI Package

00815236021046

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Dispenser