Catalog Number

-

Brand Name

Hetaida

Version/Model Number

HTD8808C

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

9b69e56f-2601-41ca-ba6c-9ddf660d8d4f

Public Version Date

August 04, 2021

Public Version Number

1

DI Record Publish Date

July 27, 2021

Package DI Number

16970289035332

Quantity per Package

40

Contains DI Package

06970289035335

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-