Veridian - 60-Second Digital Thermometer - VERIDIAN HEALTHCARE LLC

Duns Number:830437997

Device Description: 60-Second Digital Thermometer

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More Product Details

Catalog Number

-

Brand Name

Veridian

Version/Model Number

08-352

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)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K041516

Product Code Details

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Device Record Status

Public Device Record Key

43225ca0-d66a-4479-a2bf-10a06e95eb29

Public Version Date

July 06, 2018

Public Version Number

2

DI Record Publish Date

March 28, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"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