Catalog Number

-

Brand Name

iHealth

Version/Model Number

TS28B

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

-

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

785bb700-63c5-403c-a91e-806c77950739

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

April 24, 2017

Package DI Number

10856362005255

Quantity per Package

40

Contains DI Package

00856362005258

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-