Catalog Number

V8884850000

Brand Name

Genius

Version/Model Number

V8884850000

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

2b9027ce-6135-4f2a-913e-02c91a9bf54e

Public Version Date

February 15, 2019

Public Version Number

5

DI Record Publish Date

September 24, 2016

Package DI Number

40884521021137

Quantity per Package

2100

Contains DI Package

30884521021130

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE