Model: TH114
DI: 00884392020613
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
First Published: 2026-05-28
Current Version: 2026-06-05
Description
3-IN-1 RAPID READ THERMOMETER
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
a5eac643-a49f-415d-a13c-f350c02acdd2
Distribution Status:
In Commercial Distribution
DUNS Number:
118841501
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
Item #1 - Pkg Type:
Carton
Item #1 - Device ID:
10884392020610
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
2
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
00884392020613
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
00884392020613
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
Item #3 - Pkg Type:
Carton
Item #3 - Device ID:
20884392020617
Item #3 - Pkg Status:
In Commercial Distribution
Item #3 - Pkg Quantity:
12
Item #3 - Device ID Type:
Package
Item #3 - Contains DINumber:
00884392020613
Item #3 - Device ID Issuing Agency:
GS1
GMDN
Code: 14035
Name: Intermittent electronic patient thermometer
Definition:
A hand-held, battery-powered, electronic instrument designed to measure a patient's body temperature. It may comprise an electronic unit with an attached probe or be a single unit (shaped like an ordinary hand-held capillary thermometer) that detects and converts the changes in temperature into variations of some electrical characteristic, e.g., resistance or voltage. These variations of the electrical characteristics are processed in the electronic circuits and in turn displayed, for a short period, as temperature readings. Thereafter the display will automatically turn off or go into standby mode. This is a reusable device.
FDA Product Codes
FLL
Continuous Measurement Thermometer
Premarket Submissions
Submission Number:
K203731
Supplement Number:
000