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

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

f1ebbe07-f302-4c32-8dbe-08ccc248c806

Public Version Date

July 28, 2020

Public Version Number

1

DI Record Publish Date

July 20, 2020

Package DI Number

20810038630230

Quantity per Package

200

Contains DI Package

00810038630236

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-