Catalog Number

303030-

Brand Name

Genius

Version/Model Number

303030

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)

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

0c2d0ed8-4d8e-4e30-aa4d-52b91d644b66

Public Version Date

September 17, 2020

Public Version Number

1

DI Record Publish Date

September 09, 2020

Package DI Number

50192253008331

Quantity per Package

22

Contains DI Package

20192253008330

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE