Catalog Number

-

Brand Name

Easy@Home Digital Thermometer

Version/Model Number

EMT-026

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

K153149,K153149,K153149

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

8b649654-2677-4b20-8773-e3163f8c3cfa

Public Version Date

December 17, 2018

Public Version Number

3

DI Record Publish Date

August 05, 2016

Package DI Number

10850253007205

Quantity per Package

10

Contains DI Package

00850253007208

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-