FDA.reportPublic FDA data

THERMOQUICK; THERMOCLICK; THERMOCARE

Primary DI
08800065226726
Brand
THERMOQUICK; THERMOCLICK; THERMOCARE
Company
T&R BIOFAB CO.,LTD
Model
MT-3000
Catalog number
MT-3000
Device description
THERMOQUICK is a battery-powered, non-contact infrared thermometer intended to be used to monitor the body temperature of people of all ages. The reference body site of the output temperature is the axilla. A sensor built into the product measures the infrared energy emitted from the skin surface of the forehead within 2cm, so there is no need for contact with the skin. It can be used in the home or by a doctor in a clinic. It is indicated for use by people of all ages.
Published
2024-01-16
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
K222057000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222057000THERMOCLICKT&R BIOFAB CO., Ltd.2023-12-05FLL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800065228287PackageGS150In Commercial Distribution
08800065225781PreviousGS10
08800065226726PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800065228287088000652282878800065228287
08800065225781088000652257818800065225781
08800065226726088000652267268800065226726

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 Atmospheric Pressure80 KiloPascal106 KiloPascal
Handling Environment Humidity15 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature15 Degrees Celsius40 Degrees Celsius
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity0 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius50 Degrees Celsius

Regulatory Flags#

DUNS number
689846880
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800065228287THERMOQUICK; THERMOCLICK; THERMOCAREMT-3000MT-30002024-01-16
08800065225781THERMOCLICKMT-3000MT-30002022-01-26

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08698870325211FMTMETKO MEDIKAL VE TIBBI CIHAZLAR DIS TICARET LIMITED SIRKETIFLL2026-04-22