Catalog Number

-

Brand Name

FDK

Version/Model Number

FT-F33

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

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K111703,K111703,K111703,K111703

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

9eb0b009-92e3-4415-9cb8-7938b880e7e2

Public Version Date

December 04, 2020

Public Version Number

6

DI Record Publish Date

September 20, 2017

Package DI Number

00859020006208

Quantity per Package

6

Contains DI Package

10859020006199

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case