Catalog Number

-

Brand Name

HETAIDA

Version/Model Number

H8228US

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 06, 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

K180385,K180385

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

784ae26f-2f6b-451d-9e48-04baf4108261

Public Version Date

April 28, 2021

Public Version Number

2

DI Record Publish Date

April 06, 2021

Package DI Number

16970289035271

Quantity per Package

84

Contains DI Package

06970289035274

Package Discontinue Date

April 06, 2021

Package Status

Not in Commercial Distribution

Package Type

-