Catalog Number

V303030

Brand Name

Genius 2

Version/Model Number

V303030

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

Yes

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

-

Product Code

FLL

Product Code Name

Thermometer, electronic, clinical

Public Device Record Key

203a81d1-ec81-4886-9a46-f2345502e906

Public Version Date

February 15, 2019

Public Version Number

5

DI Record Publish Date

September 24, 2016

Package DI Number

10884521149243

Quantity per Package

2112

Contains DI Package

20884521149240

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE