Catalog Number

-

Brand Name

Braun

Version/Model Number

IRT6520BUS

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

K103800,K103800

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

99743c30-0ea6-4317-9298-753f76619df1

Public Version Date

May 27, 2020

Public Version Number

2

DI Record Publish Date

August 01, 2018

Package DI Number

10328785001911

Quantity per Package

6

Contains DI Package

00328785001914

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE