Catalog Number

-

Brand Name

Hetaida

Version/Model Number

HTD8813C

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

Yes

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

92b26dee-97e7-4d66-89c2-c7f37f205ff1

Public Version Date

March 29, 2022

Public Version Number

1

DI Record Publish Date

March 21, 2022

Package DI Number

16970289035493

Quantity per Package

120

Contains DI Package

06970289035496

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-