Catalog Number

431

Brand Name

Essentials

Version/Model Number

431

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"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K100953,K100953,K100953

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

9eda34b7-37e8-43fb-a8f3-f6fe174497e2

Public Version Date

December 04, 2020

Public Version Number

2

DI Record Publish Date

July 31, 2020

Package DI Number

00634782899653

Quantity per Package

6

Contains DI Package

00634782098278

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Pack