Catalog Number

-

Brand Name

joyhicare

Version/Model Number

H8830US

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

K203332,K203332

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

2766a43f-b3bc-489a-8a96-3362edbe779f

Public Version Date

June 21, 2022

Public Version Number

1

DI Record Publish Date

June 11, 2022

Package DI Number

16970289035523

Quantity per Package

100

Contains DI Package

06970289035526

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-