Catalog Number

Art.- No. 795.79

Brand Name

Beurer

Version/Model Number

FT58 IR Ear Thermometer

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

-

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

f90f1138-8245-4e32-9136-3e9e47eaa4ab

Public Version Date

February 25, 2019

Public Version Number

4

DI Record Publish Date

November 18, 2016

Package DI Number

20852547004713

Quantity per Package

12

Contains DI Package

10852547004716

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case