Catalog Number

-

Brand Name

Braun

Version/Model Number

BFH125US

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

-

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

K033820,K033820

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

d0c93ad5-acf9-4238-a6fe-0a994f5cf451

Public Version Date

December 04, 2020

Public Version Number

5

DI Record Publish Date

November 15, 2016

Package DI Number

10328785000624

Quantity per Package

6

Contains DI Package

00328785000627

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case