Catalog Number

-

Brand Name

Easy@Home Digital Basal Thermometer

Version/Model Number

EBT100

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

K122912,K122912

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

d856e379-d694-4701-9c77-f9c7b015920c

Public Version Date

August 08, 2019

Public Version Number

1

DI Record Publish Date

July 31, 2019

Package DI Number

10850003180035

Quantity per Package

200

Contains DI Package

00850003180038

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton