Catalog Number

202020

Brand Name

Filac

Version/Model Number

202020

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

July 01, 2023

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)

Yes

Over the Counter (OTC)

-

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

db55eb62-ff80-486f-8945-149eba818eda

Public Version Date

October 11, 2021

Public Version Number

8

DI Record Publish Date

September 24, 2016

Package DI Number

20884521000138

Quantity per Package

5000

Contains DI Package

10884521210318

Package Discontinue Date

July 01, 2023

Package Status

In Commercial Distribution

Package Type

CASE