Catalog Number

-

Brand Name

Easy@Home Digital Basal Thermometer

Version/Model Number

EBT-100 PURPLE

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,K122912

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

9ec1e876-fbc4-4667-82c4-ee21efaed959

Public Version Date

January 01, 2021

Public Version Number

2

DI Record Publish Date

December 01, 2020

Package DI Number

10810038631605

Quantity per Package

200

Contains DI Package

00810038631608

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-