KONQUEST - Forehead and Ear Infrared Thermometer - Upgraded - KONQUEST GROUP INC

Duns Number:080939375

Device Description: Forehead and Ear Infrared Thermometer - Upgraded Firmware

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More Product Details

Catalog Number

-

Brand Name

KONQUEST

Version/Model Number

KDT-2106 V2

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

K172795

Product Code Details

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Device Record Status

Public Device Record Key

63048ad0-098e-4f98-82c4-ad4ceb7a9c81

Public Version Date

May 23, 2022

Public Version Number

3

DI Record Publish Date

November 01, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"KONQUEST GROUP INC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 9