Model: A201
DI: 06947832500008
Status: Update
MRI: MR Unsafe
Single-use: No
Rx: No
OTC: No
First Published: 2026-04-30
Current Version: 2026-05-15
Distribution End: 2026-04-30
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
2
Record Key:
8378dfa2-8a86-4497-8eb0-81f7c50f9ad3
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:
06947832500008
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 17888
Name: Infrared patient thermometer, skin
Definition:
A hand-held, electrically-powered instrument designed to estimate the temperature of a site on the skin (e.g., axilla, forehead) by measurement of body infrared emissions at this particular point. It provides a method to determine temperature patterns or variations on the surface of the skin (e.g., due to differences in perfusion). This device may be used in the home. This is a reusable device.
FDA Product Codes
FLL
Thermometer, Electronic, Clinical
Premarket Submissions
Submission Number:
K171578
Supplement Number:
000