Fever Thermometer - BETTER BASICS, INC.

Duns Number:013029698

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More Product Details

Catalog Number

-

Brand Name

Fever Thermometer

Version/Model Number

MP-IRT450

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

K131243,K131243,K131243

Product Code Details

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Device Record Status

Public Device Record Key

dd4f8990-18a9-4c16-b006-482659a93bcb

Public Version Date

December 04, 2020

Public Version Number

5

DI Record Publish Date

September 15, 2017

Additional Identifiers

Package DI Number

00817746021325

Quantity per Package

100

Contains DI Package

00817746025552

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"BETTER BASICS, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 2