Catalog Number

-

Brand Name

Braun

Version/Model Number

IRT6515AM

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

60caeb98-e4d3-4d4c-b65f-e14e190e404d

Public Version Date

October 07, 2020

Public Version Number

1

DI Record Publish Date

September 29, 2020

Package DI Number

10328785004387

Quantity per Package

48

Contains DI Package

00328785004380

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case