Catalog Number

-

Brand Name

Braun

Version/Model Number

LF40BBUS

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

K103800,K103800,K103800,K103800

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

65097398-ff56-4657-9062-98256490b3e7

Public Version Date

May 27, 2020

Public Version Number

4

DI Record Publish Date

September 09, 2016

Package DI Number

10328785000549

Quantity per Package

24

Contains DI Package

00328785000542

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case