Truer Medical, Inc.

FDA UDI

Class II (US FDA UDI)

by Truer Medical, Inc.

Identity

Trade Name: Truer Medical, Inc. FDA UDI
Generic Name: Infrared patient thermometer, skin FDA UDI
Device Name: The Truer Medical Skin Temperature Sensor is designed for monitoring a patient’s skin surface temperature during surgical procedures, postoperative recovery, or whenever a clinician needs to accurately assess patient skin temperature. The Truer Medical, Inc. Skin Sensor has reflective silver material on one side to insulate the sensor from heat generated by operating room lights or heat lamps. FDA UDI
Model / Reference: TP 400 FDA UDI
Description: The Truer Medical Skin Temperature Sensor is designed for monitoring a patient’s skin surface temperature during surgical procedures, postoperative recovery, or whenever a clinician needs to accurately assess patient skin temperature. The Truer Medical, Inc. Skin Sensor has reflective silver material on one side to insulate the sensor from heat generated by operating room lights or heat lamps. FDA UDI

Identifiers

Catalog Number: TP 400 FDA UDI
Primary DI / UDI-DI: 00859290006144 FDA UDI
510(k) Number: K101244 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

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

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Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

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Lot / Batch Number

Yes

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Serial Number

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Expiration Date

Yes

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Manufacturing Date

Yes

FDA UDI

Category: Infrared patient thermometer, skin

Truer Medical, Inc. by Truer Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Infrared patient thermometer, skin.

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Diagnostix™ — American Diagnostic Corporation · Class II
Famidoc — FAMIDOC USA, INC. · Class II
Sinocare Non-contact Infrared Thermometer — Alicn Medical Shenzhen, Inc. · Class II
Famidoc — Famidoc Technology Company Limited · Class II
DR.TALBOT'S Non-contact Infrared Thermometer — Alicn Medical Shenzhen, Inc. · Class II
Berrcom — Guangzhou Berrcom Medical Device Co., Ltd · Class II

Cleared under the same submission

K101244 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Truer Medical, Inc.

Sources (1)

FDA UDI 5619baaa-0db5-4f7e-ac7c-12c9be27e47b 36 fields · synced May 30, 2026