Catalog Number

-

Brand Name

FDK

Version/Model Number

BT-A41CN

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

e17f7ece-a2d2-47c7-8247-200028fc16e6

Public Version Date

April 13, 2020

Public Version Number

6

DI Record Publish Date

December 21, 2016

Package DI Number

10859020006038

Quantity per Package

240

Contains DI Package

00859020006031

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case