Catalog Number

-

Brand Name

iHealth

Version/Model Number

PT3

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)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K200531,K200531

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

26105e6c-b366-42e6-943a-d20e7f683149

Public Version Date

August 15, 2022

Public Version Number

3

DI Record Publish Date

July 31, 2020

Package DI Number

10856362005040

Quantity per Package

24

Contains DI Package

00856362005043

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-