Catalog Number

-

Brand Name

McKesson

Version/Model Number

01-412GM-00

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

-

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

K940686,K940686,K940686

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

7478b594-a651-4412-a4e8-3ba589862f31

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

December 09, 2016

Package DI Number

40612479134735

Quantity per Package

12

Contains DI Package

20612479134724

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case