Catalog Number

-

Brand Name

iHealth

Version/Model Number

PT1

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K202791,K202791

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

becc114f-e9e8-4b1c-a47d-1fc22e254bd6

Public Version Date

April 09, 2021

Public Version Number

1

DI Record Publish Date

April 01, 2021

Package DI Number

10856362005811

Quantity per Package

100

Contains DI Package

00856362005814

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-