Catalog Number

-

Brand Name

Hetaida

Version/Model Number

HTD8222US

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

K200781,K200781

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

75befd27-ef79-484d-ada4-208b2ee0030f

Public Version Date

November 15, 2021

Public Version Number

1

DI Record Publish Date

November 06, 2021

Package DI Number

16970289035349

Quantity per Package

36

Contains DI Package

06970289035342

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-