Catalog Number

-

Brand Name

Hetaida

Version/Model Number

HTD8813C

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

February 26, 2021

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

-

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

a8b91056-17de-44f9-9fc8-335a353eebd0

Public Version Date

April 28, 2021

Public Version Number

2

DI Record Publish Date

February 25, 2021

Package DI Number

16970289035219

Quantity per Package

84

Contains DI Package

06970289035212

Package Discontinue Date

February 26, 2021

Package Status

Not in Commercial Distribution

Package Type

-