Catalog Number

-

Brand Name

HOMEDICS

Version/Model Number

TIE-240-BABY

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Conditional

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

-

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

7e84c73d-747a-4f17-9334-c1a82f08fa09

Public Version Date

January 19, 2021

Public Version Number

1

DI Record Publish Date

January 11, 2021

Package DI Number

10031262101232

Quantity per Package

6

Contains DI Package

00031262101235

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case