AccessGUDID - DEVICE: Mesanfit (07958909771664)

GUDID

Device Identifier (DI) Information

Brand Name: Mesanfit
Version or Model: HTD8813C
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: Hetaida Technology Co., Ltd

Primary DI Number: 07958909771664
Issuing Agency: GS1
Commercial Distribution End Date: August 11, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 544474402 *Terms of Use

Device Description: Non Contact Infrared Body Thermometer

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 [?]
Premarket Submission Number Not Available/Not Released

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
Storage Environment Temperature: between -20 and 55 Degrees Celsius
Storage Environment Humidity: between 0 and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Handling Environment Temperature: between 15 and 35 Degrees Celsius
Handling Environment Humidity: between 0 and 85 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 53926d3c-f10f-4f46-8afd-d959feef122d
Public Version Date: April 28, 2021
Public Version Number: 3
DI Record Publish Date: August 04, 2020