Model: A202E
DI: 06947832500664
Status: New
MRI: MR Unsafe
Single-use: No
Rx: No
OTC: No
First Published: 2026-04-30
Current Version: 2026-05-08
Distribution End: 2026-04-30
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
0cc3aba5-5eac-45b0-aaa6-556969068567
Distribution Status:
Not in Commercial Distribution
DUNS Number:
529372064
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
No
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
06947832500664
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 17887
Name: Infrared patient thermometer, ear
Definition:
A hand-held, battery-powered, electronic instrument designed to measure the temperature of a patient's ear canal. In most cases it is intended to estimate the internal (core) temperature of the body by measurement of infrared radiation from within the auditory canal. It may claim to measure directly the infrared emissions from the tympanic membrane. An infrared ear thermometer usually displays values corrected by an offset of actual patient oral/rectal temperatures. This is a reusable device.
FDA Product Codes
FLL
Thermometer, Electronic, Clinical
Premarket Submissions
Submission Number:
K171578
Supplement Number:
000