Model: DMT-101
DI: 06970392212470
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: Yes
First Published: 2026-05-20
Current Version: 2026-05-28
Description
Digital Thermometer
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
fc3fb3e2-51ed-45dd-895b-9d17a3450af4
Distribution Status:
In Commercial Distribution
DUNS Number:
544392778
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:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Item #1 - Pkg Type:
1
Item #1 - Device ID:
16970392211708
Item #1 - Pkg Status:
Not in Commercial Distribution
Item #1 - Pkg Quantity:
10
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
06970392212470
Item #1 - Pkg Discontinue Date:
2020-09-04
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
06970392212470
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
Item #3 - Pkg Type:
2
Item #3 - Device ID:
26970392211705
Item #3 - Pkg Status:
Not in Commercial Distribution
Item #3 - Pkg Quantity:
300
Item #3 - Device ID Type:
Package
Item #3 - Contains DINumber:
16970392211708
Item #3 - Pkg Discontinue Date:
2020-09-04
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
SDV
Clinical Electronic Thermometer