Catalog Number

-

Brand Name

McKesson

Version/Model Number

3068

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"

Yes

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

0be6be67-606f-4c19-b225-d0c5d91dc250

Public Version Date

June 03, 2022

Public Version Number

5

DI Record Publish Date

December 09, 2016

Package DI Number

40612479195965

Quantity per Package

22

Contains DI Package

20612479195954

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case