BEUDAMED

FDA UDI In Commercial Distribution 🇺🇸 United States

THERMOCLICK

DI: 08800065225781 · Model: MT-3000 · T&R BIOFAB CO.,LTD

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Product Codes

1

GMDN Terms

1

Identifiers

2

Pkg Device Count

1

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Basic Information

Brand Name: THERMOCLICK
Primary DI: 08800065225781
Version / Model: MT-3000
Catalog Number: MT-3000
Company Name: T&R BIOFAB CO.,LTD
Labeler DUNS: 689846880
Distribution Status: In Commercial Distribution
Device Count in Pkg: 1
Record Status: Published
Publish Date: 2022-01-26
Public Version: 1
Public Version Date: 2022-02-03
Public Version Status: New
Public Device Record Key: 4b142654-44c5-4c76-9783-f0730d573544

Device Characteristics

Single Use: No
Prescription Use (Rx): No
Over the Counter (OTC): No
Kit: No
Combination Product: No
HCT/P: No
Contains NRL: No
Not Made with NRL: No
MRI Safety: Labeling does not contain MRI Safety Information
Direct Marking Exempt: No
PM Exempt: Yes
Has Serial Number: Yes
Has Lot/Batch Number: No
Has Manufacturing Date: Yes
Has Expiration Date: No
Has Donation ID: No

Sterilization

Is Sterile: No
Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FLL	Thermometer, Electronic, Clinical	General Hospital	880.2910	2

GMDN Terms

Code	Name	Definition	Implantable	Status
17888	Infrared patient thermometer, skin	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08800065225781	GS1
Package	08800065225798	GS1	Box	50	In Commercial Distribution

Storage Conditions

Type: Handling Environment Atmospheric Pressure
Temperature Range: 80 – 106 KiloPascal
Type: Handling Environment Temperature
Temperature Range: 15 – 40 Degrees Celsius
Type: Handling Environment Humidity
Temperature Range: 15 – 90 Percent (%) Relative Humidity