Model: YJ600
DI: 06975039337868
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
First Published: 2026-05-09
Current Version: 2026-05-18
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
196d771c-830e-4320-a920-b66246f4a231
Distribution Status:
In Commercial Distribution
DUNS Number:
417871037
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
Yes
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
06975039337868
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 63711
Name: Infrared patient thermometer, ear/skin
Definition:
A hand-held, battery-powered, electronic instrument designed to measure: 1) the temperature of a patient's ear canal, typically to estimate the internal (core) temperature; and 2) the temperature of a site on the skin (e.g., axilla, forehead), by measurement of body infrared emissions. It typically includes both a skin-surface tip and an intra-aural tip. This device is intended for use in the home or healthcare facility. This is a reusable device.
FDA Product Codes
FLL
Continuous Measurement Thermometer
Premarket Submissions
Submission Number:
K232473
Supplement Number:
000