Catalog Number

-

Brand Name

Easy@Home Rectal Digital Thermometer

Version/Model Number

EMT-027

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

K163518,K163518

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

8c16d3b0-4718-457f-9947-4ca1b9841899

Public Version Date

October 28, 2021

Public Version Number

1

DI Record Publish Date

October 20, 2021

Package DI Number

10810038632053

Quantity per Package

200

Contains DI Package

00810038632056

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-