Catalog Number

-

Brand Name

Medical/Surface Thermometer

Version/Model Number

52225-MED

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 24, 2020

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"

-

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

K121428

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

a8cd9bcb-35e8-4fd1-b421-2c65e09adbc2

Public Version Date

January 27, 2022

Public Version Number

3

DI Record Publish Date

June 17, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-