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ProScan Non-Contact Infrared Thermometer by Physio Logic

FDA UDI

Class II (US FDA UDI)

by A.M.G. Médicale Inc

Identity

Trade Name
ProScan Non-Contact Infrared Thermometer by Physio Logic FDA UDI
Generic Name
Infrared patient thermometer, skin FDA UDI
Device Name
3 in 1 Thermometer: Body, Room, Liquids and surfaces Non-contact infrared probe Professional Accuracy Faster and more precise than an ear thermometer Non-Contact up to 1- 2" (3 cm - 5 cm) distance from forehead. This means a greatly reduced risk of contagion, without the need for probe covers. Back-lit screen with colour-coded fever alert: green for normal, orange for a low fever and red for a fever of or above 38 C (100.4 F). Fully programmable alerts can be set to detect fever for a specific age group or illness. Use it to ensure that food temperature is safe before serving. Prevent scalding due to hot bath water. Audio alert signals peak temperature and fever. Voice feature can assist users with impaired vision and can be set to English, French, Spanish or mute. Keeps the last 32 temperature readings in memory. Displays in C or F. Auto shut-off for extended battery life. Longevity: 40,000 readings. 2 alkaline AA batteries included. FDA UDI
Model / Reference
016-660 FDA UDI
Description
3 in 1 Thermometer: Body, Room, Liquids and surfaces Non-contact infrared probe Professional Accuracy Faster and more precise than an ear thermometer Non-Contact up to 1- 2" (3 cm - 5 cm) distance from forehead. This means a greatly reduced risk of contagion, without the need for probe covers. Back-lit screen with colour-coded fever alert: green for normal, orange for a low fever and red for a fever of or above 38 C (100.4 F). Fully programmable alerts can be set to detect fever for a specific age group or illness. Use it to ensure that food temperature is safe before serving. Prevent scalding due to hot bath water. Audio alert signals peak temperature and fever. Voice feature can assist users with impaired vision and can be set to English, French, Spanish or mute. Keeps the last 32 temperature readings in memory. Displays in C or F. Auto shut-off for extended battery life. Longevity: 40,000 readings. 2 alkaline AA batteries included. FDA UDI

Identifiers

Primary DI / UDI-DI
00057565166603 FDA UDI
FDA Product Code
FLL FDA UDI
GMDN Term
Infrared patient thermometer, skin FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.2910 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Infrared patient thermometer, skin

ProScan Non-Contact Infrared Thermometer by Physio Logic by A.M.G. Médicale Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Infrared patient thermometer, skin.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
A.M.G. Médicale Inc

Sources (1)

  • FDA UDI 47f890f7-845e-42b7-ad6f-7808fd64566c 34 fields · synced May 30, 2026