Catalog Number

-

Brand Name

AUPO

Version/Model Number

FT-F21

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

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

d6dab353-301f-4eee-9d7b-1c518c674271

Public Version Date

December 01, 2020

Public Version Number

1

DI Record Publish Date

November 23, 2020

Package DI Number

16955647600070

Quantity per Package

16

Contains DI Package

06955647600073

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Box