Catalog Number

-

Brand Name

BYD

Version/Model Number

HTD8813C

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 20, 2020

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

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

4b7c0d3d-400f-43a0-b590-17d432e88e42

Public Version Date

April 28, 2021

Public Version Number

3

DI Record Publish Date

April 17, 2020

Package DI Number

16970289030085

Quantity per Package

40

Contains DI Package

06970289030088

Package Discontinue Date

April 20, 2020

Package Status

Not in Commercial Distribution

Package Type

-