FDA.reportPublic FDA data

THERMOFINDER

Primary DI
08800132200161
Brand
THERMOFINDER
Company
HuBDIC Co., Ltd.
Model
FS-300
Device description
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.
Published
2022-04-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
FLLThermometer, Electronic, Clinical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FLLContinuous Measurement ThermometerGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K130361000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K130361000THERMOFINDER; THERMOCAREHubdic Co., Ltd.2013-04-02FLL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800132200161PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800132200161088001322001618800132200161

GMDN Terms#

Term, Definition table
TermDefinition
Infrared patient thermometer, skinA hand-held, electrically-powered instrument designed to estimate the temperature of a site on the skin (e.g., axilla, forehead) by measurement of body infrared emissions at this particular point. It provides a method to determine temperature patterns or variations on the surface of the skin (e.g., due to differences in perfusion). This device may be used in the home. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Humidity15 Percent (%) Relative Humidity93 Percent (%) Relative Humidity
Handling Environment Temperature16 Degrees Celsius40 Degrees Celsius
Storage Environment Humidity15 Percent (%) Relative Humidity93 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
688454128
Device count
1
DM exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800132210160HuBDIC Nasal AspiratorHNA-20B2022-09-07
08800132210177HuBDIC Nasal AspiratorHNA-20P2022-09-07
08800132200178THERMOFINDERFS-3012022-04-13
08800132200239Thermofinder SFS-7002022-04-13
08800132200246Thermofinder SFS-700pro2022-04-13
08800132200413Fever GardeHMT-1002022-04-13

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06926347900459joybabeShenzhen Brav Electronic Technologies Co., Ltd.FLL2026-06-01
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08698870325211FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIFLL2026-04-22