AccessGUDID - DEVICE: Thermofinder S (08800132200246)

GUDID

Device Identifier (DI) Information

Brand Name: Thermofinder S
Version or Model: FS-700pro
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: HuBDIC Co., Ltd.

Primary DI Number: 08800132200246
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 688454128 *Terms of Use

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

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 [?]
K130361	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 16 and 40 Degrees Celsius
Handling Environment Humidity: less than 95 Percent (%) Relative Humidity
Storage Environment Temperature: between -20 and 50 Degrees Celsius
Storage Environment Humidity: less than 95 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: cec5c423-b58e-49b4-9f90-bf1e7ec55446
Public Version Date: April 21, 2022
Public Version Number: 1
DI Record Publish Date: April 13, 2022