Catalog Number

-

Brand Name

FDK

Version/Model Number

BT-A31

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

K101387,K101387,K101387

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

1e5072d6-f274-432f-8e7d-c5ed2c3ae1e0

Public Version Date

April 13, 2020

Public Version Number

3

DI Record Publish Date

December 10, 2019

Package DI Number

00859020006352

Quantity per Package

120

Contains DI Package

00859020006178

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case