Catalog Number

-

Brand Name

YOOKO

Version/Model Number

HTD8216C

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

K180385,K180385

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

b20b4aaa-b260-42e9-b307-aaeb8eec1f73

Public Version Date

January 13, 2022

Public Version Number

1

DI Record Publish Date

January 05, 2022

Package DI Number

16970289035486

Quantity per Package

100

Contains DI Package

06970289035489

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-