Catalog Number

202020

Brand Name

CARDINAL HEALTH

Version/Model Number

202020

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

75725fe5-2c73-4819-9181-61e5d01408c7

Public Version Date

January 27, 2021

Public Version Number

2

DI Record Publish Date

August 31, 2020

Package DI Number

50192253006207

Quantity per Package

250

Contains DI Package

20192253006206

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE