AccessGUDID - DEVICE: THERMOQUICK; THERMOCLICK; THERMOCARE (08800065226726)

GUDID

Device Identifier (DI) Information

Brand Name: THERMOQUICK; THERMOCLICK; THERMOCARE
Version or Model: MT-3000
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MT-3000
Company Name: T&R BIOFAB CO.,LTD

Primary DI Number: 08800065226726
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 689846880 *Terms of Use
Previous DI: 08800065225781

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.

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FLL	Thermometer, Electronic, Clinical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K222057	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Temperature: between 15 and 40 Degrees Celsius
Handling Environment Humidity: between 15 and 90 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 80 and 106 KiloPascal
Storage Environment Temperature: between -20 and 50 Degrees Celsius
Storage Environment Humidity: between 0 and 95 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 2106799e-43d4-4909-8ca1-2dc629d763a7
Public Version Date: January 24, 2024
Public Version Number: 1
DI Record Publish Date: January 16, 2024