Veridian - Veridian Talking Ear/Forehead Thermometer - VERIDIAN HEALTHCARE LLC

Duns Number:830437997

Device Description: Veridian Talking Ear/Forehead Thermometer

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More Product Details

Catalog Number

09-342

Brand Name

Veridian

Version/Model Number

09-342

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

-

Product Code Details

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Device Record Status

Public Device Record Key

9a09a042-2b54-4519-9ec5-9de339eb743f

Public Version Date

December 04, 2020

Public Version Number

2

DI Record Publish Date

September 23, 2019

Additional Identifiers

Package DI Number

10845717009222

Quantity per Package

24

Contains DI Package

00845717009225

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Master Carton

"VERIDIAN HEALTHCARE LLC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 127