Model: HTD8816C
DI: 00199874040318
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: Yes
First Published: 2026-05-12
Current Version: 2026-05-20
Description
VIEK Non-contact Infrared Body Thermometer
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
a1f4c559-d984-4a89-88cb-7097ce63ae48
Distribution Status:
In Commercial Distribution
DUNS Number:
544474402
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00199874040318
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 17888
Name: Infrared patient thermometer, skin
Definition:
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.
FDA Product Codes
FLL
Continuous Measurement Thermometer
Environmental Conditions
Item #1 - Storage Handling Low - @attributes - Unit:
Percent (%) Relative Humidity
Item #1 - Storage Handling Low - @attributes - Value:
0
Item #1 - Storage Handling High - @attributes - Unit:
Percent (%) Relative Humidity
Item #1 - Storage Handling High - @attributes - Value:
93
Item #1 - Storage Handling Type:
Storage Environment Humidity
Item #2 - Storage Handling Low - @attributes - Unit:
KiloPascal
Item #2 - Storage Handling Low - @attributes - Value:
70
Item #2 - Storage Handling High - @attributes - Unit:
KiloPascal
Item #2 - Storage Handling High - @attributes - Value:
106
Item #2 - Storage Handling Type:
Storage Environment Atmospheric Pressure
Item #3 - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Item #3 - Storage Handling Low - @attributes - Value:
15
Item #3 - Storage Handling High - @attributes - Unit:
Degrees Celsius
Item #3 - Storage Handling High - @attributes - Value:
40
Item #3 - Storage Handling Type:
Handling Environment Temperature
Item #4 - Storage Handling Low - @attributes - Unit:
Percent (%) Relative Humidity
Item #4 - Storage Handling Low - @attributes - Value:
0
Item #4 - Storage Handling High - @attributes - Unit:
Percent (%) Relative Humidity
Item #4 - Storage Handling High - @attributes - Value:
85
Item #4 - Storage Handling Type:
Handling Environment Humidity
Item #5 - Storage Handling Low - @attributes - Unit:
KiloPascal
Item #5 - Storage Handling Low - @attributes - Value:
70
Item #5 - Storage Handling High - @attributes - Unit:
KiloPascal
Item #5 - Storage Handling High - @attributes - Value:
106
Item #5 - Storage Handling Type:
Handling Environment Atmospheric Pressure
Item #6 - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Item #6 - Storage Handling Low - @attributes - Value:
-20
Item #6 - Storage Handling High - @attributes - Unit:
Degrees Celsius
Item #6 - Storage Handling High - @attributes - Value:
55
Item #6 - Storage Handling Type:
Storage Environment Temperature