Catalog Number

-

Brand Name

HOMEWELL ESSENTIALS

Version/Model Number

JXB-183

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"

Yes

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

-

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

420570c6-2881-4f6c-86d1-eb2735f5c7b8

Public Version Date

December 04, 2020

Public Version Number

2

DI Record Publish Date

August 20, 2020

Package DI Number

26947656113075

Quantity per Package

40

Contains DI Package

16947656113078

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

cartoon