Catalog Number

-

Brand Name

HOMEDICS

Version/Model Number

TIE-300-WT

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

K182597,K182597,K182597

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Public Device Record Key

a18bdb33-745d-4855-ad3c-db69152ca3c0

Public Version Date

April 13, 2022

Public Version Number

2

DI Record Publish Date

April 01, 2021

Package DI Number

10031262101249

Quantity per Package

6

Contains DI Package

00031262101242

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case