AccessGUDID - DEVICE: Non-contact Infrared Thermometer DT-100 (18800003445537)

GUDID

Device Identifier (DI) Information

Brand Name: Non-contact Infrared Thermometer DT-100
Version or Model: DT-100
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 00885
Company Name: Mediana.CO.LTD

Primary DI Number: 18800003445537
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 687879726 *Terms of Use

Device Description: The DT-100 non-contact infrared thermometer is intended to be used to measure temperature for consumers including adult, pediatric and neonatal using infrared sensors. It can detect the body temperature from human's face. The DT-100 infrared thermometer can be used by consumers in household environment.

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 [?]
K160358	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 47d050f2-5fc7-4bdb-b730-f7412a2e9421
Public Version Date: December 04, 2020
Public Version Number: 2
DI Record Publish Date: July 03, 2018