Catalog Number

PFT55E

Brand Name

FeverTemp Ultra

Version/Model Number

PFT55E

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

116c1378-67f0-446a-90a4-629311fe89d9

Public Version Date

February 24, 2020

Public Version Number

3

DI Record Publish Date

September 24, 2016

Package DI Number

30815236020613

Quantity per Package

12

Contains DI Package

20815236020616

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Poly Bag