Catalog Number

303030

Brand Name

Genius 2

Version/Model Number

303030

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

November 30, 2023

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

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

FLL

Product Code Name

Thermometer, electronic, clinical

Public Device Record Key

5aeb8bc7-c544-4ae0-96d5-0b9eb2c9cb61

Public Version Date

September 10, 2020

Public Version Number

7

DI Record Publish Date

September 24, 2016

Package DI Number

20884521000343

Quantity per Package

2112

Contains DI Package

10884521000346

Package Discontinue Date

July 01, 2023

Package Status

In Commercial Distribution

Package Type

CASE