Model: PCIT01
Catalog: PCIT01
DI: 10840330706565
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: Yes
First Published: 2026-05-05
Current Version: 2026-05-13
Description
Non-Contact Infrared Thermometer 1ea/bx 60ea/cs
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
7db625a4-e3c6-4ae5-92c8-5062397ea6e3
Distribution Status:
In Commercial Distribution
DUNS Number:
107071289
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Item #1 - Pkg Type:
Case
Item #1 - Device ID:
30840330706569
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
60
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
10840330706565
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
10840330706565
Item #2 - Device ID Type:
Primary
Item #2 - Device ID 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
SDV
Clinical Electronic Thermometer
Environmental Conditions
Item #1 - Storage Handling Type:
Special Storage Condition, Specify
Item #1 - Storage Handling Special Condition Text:
Store between -13 and 131 F, 15 - 95% Humidity. Keep dry and away from sunlight.
Item #2 - Storage Handling Low - @attributes - Unit:
Degrees Fahrenheit
Item #2 - Storage Handling Low - @attributes - Value:
-13
Item #2 - Storage Handling High - @attributes - Unit:
Degrees Fahrenheit
Item #2 - Storage Handling High - @attributes - Value:
131
Item #2 - Storage Handling Type:
Storage Environment Temperature