← Back to catalogue

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
TAT2000C Original Temporal Scanner FDA UDI
Model / Reference
TAT2000C Original FDA UDI
Description
TAT2000C Original Temporal Scanner FDA UDI

Identifiers

Catalog Number
140050, 144060, 140033 FDA UDI
Primary DI / UDI-DI
00834098002918 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
Not 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

No

FDA UDI

Exergen Temporal Scanner by Exergen Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K011291 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Exergen Corporation

Sources (1)

  • FDA UDI 9e497dcb-83f3-446d-93cf-7ab680d35f4f 38 fields · synced Jun 9, 2026