Catalog Number

-

Brand Name

YOOKO

Version/Model Number

HTD8823US

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

-

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

K200159,K200159

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

a84308bf-45cb-4a5a-9eb9-4edb4a272461

Public Version Date

June 08, 2022

Public Version Number

1

DI Record Publish Date

May 31, 2022

Package DI Number

16970289035516

Quantity per Package

84

Contains DI Package

06970289035519

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-