Catalog Number

-

Brand Name

Braun

Version/Model Number

BNT400BSP

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)

Yes

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

-

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

39620ba4-a47d-4931-85d3-0fe8408afd44

Public Version Date

December 04, 2020

Public Version Number

2

DI Record Publish Date

September 29, 2020

Package DI Number

10328785005988

Quantity per Package

6

Contains DI Package

00328785005981

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE