HOMEDICS - Infrared Ear/Forehead Thermometer - FKA DISTRIBUTING CO., LLC

Duns Number:183280973

Device Description: Infrared Ear/Forehead Thermometer

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More Product Details

Catalog Number

-

Brand Name

HOMEDICS

Version/Model Number

TIE-300-BK

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

Product Code Details

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Device Record Status

Public Device Record Key

3bf4f8ec-6e2c-4319-9614-55c13b83fd0d

Public Version Date

February 08, 2022

Public Version Number

1

DI Record Publish Date

January 31, 2022

Additional Identifiers

Package DI Number

10031262101355

Quantity per Package

6

Contains DI Package

00031262101358

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"FKA DISTRIBUTING CO., LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 23
2 A medical device with a moderate to high risk that requires special controls. 44