THERMOFINDER - The Non-Contact Infrared Thermometer is an - HuBDIC Co., Ltd.

Duns Number:688454128

Device Description: The Non-Contact Infrared Thermometer is an electronic thermometer using an infrared sensor The Non-Contact Infrared Thermometer is an electronic thermometer using an infrared sensor (thermopile) tomeasure forehead temperature. Its operation is based on measuring the natural thermal radiation emanating fromthe forehead and the adjacent surfaces. Its software performs a calculation that factors in room temperature, andthen a calculated temperature is displayed on the LCD.

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More Product Details

Catalog Number

-

Brand Name

THERMOFINDER

Version/Model Number

FS-301

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

K130361

Product Code Details

Product Code

FLL

Product Code Name

Thermometer, Electronic, Clinical

Device Record Status

Public Device Record Key

f9316855-9744-4aca-bf3c-08e4fc9af341

Public Version Date

April 21, 2022

Public Version Number

1

DI Record Publish Date

April 13, 2022

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"HUBDIC CO., LTD." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2
2 A medical device with a moderate to high risk that requires special controls. 5