Exergen Temporal Scanner

FDA UDI

Class II (US FDA UDI)

by Exergen Corporation

Identity

Trade Name: Exergen Temporal Scanner FDA UDI
Generic Name: Infrared patient thermometer, skin FDA UDI
Device Name: Kit with TAT5000 Oral Calibration & TAT2000C Temporal Scanner FDA UDI
Model / Reference: TAT5000 FDA UDI
Description: Kit with TAT5000 Oral Calibration & TAT2000C Temporal Scanner FDA UDI

Identifiers

Catalog Number: 124375-P FDA UDI
Primary DI / UDI-DI: 10834098002038 FDA UDI
510(k) Number: K011291 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

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

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Expiration Date

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Manufacturing Date

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MRI Safety

MR Conditional FDA UDI

Category: Infrared patient thermometer, skin

Exergen Temporal Scanner: A precise and user-friendly infrared patient thermometer for accurate temperature readings on the skin, suitable for home use or clinical applications.

Similar devices

Also classified as Infrared patient thermometer, skin.

TytoHome — TYTO CARE LTD · Class II
ALPHAMED — Shenzhen Urion Technology Co., Ltd. · Class II
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

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: Exergen Corporation

Sources (1)

FDA UDI 3619bdd3-5bbb-4b10-8c15-078e50fbca9a 37 fields · synced Jul 17, 2026