Device
intended to measure human body temperature
Manufacturer
HANGZHOU HUA'AN MEDICAL & HEALTH INSTRUMENTS CO.,LTD.
HANGZHOU HUA'AN MEDICAL & HEALTH INSTRUMENTS CO.,LTD.
Model: DT-01A
DI: 06931562703433
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
First Published: 2026-05-15
Current Version: 2026-05-25
Description
intended to measure human body temperature
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
eaea9993-e3b3-4201-b1ca-c08d6e4a2061
Distribution Status:
In Commercial Distribution
DUNS Number:
544611767
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
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:
06931562703433
Type:
Primary
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
Thermometer, Electronic, Clinical