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TempAlert II

FDA UDI

Class II (US FDA UDI)

by Lcr Hallcrest, Llc.

Identity

Trade Name
TempAlert II FDA UDI
Generic Name
Liquid-crystal patient thermometer, single-use FDA UDI
Device Name
TempAlert II Liquid Crystal Temperature Trend Indicator FDA UDI
Model / Reference
8501-II FDA UDI
Description
TempAlert II Liquid Crystal Temperature Trend Indicator FDA UDI

Identifiers

Catalog Number
8501-II FDA UDI
Primary DI / UDI-DI
10815236020329 FDA UDI
FDA Product Code
KPD FDA UDI
GMDN Term
Liquid-crystal patient thermometer, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
880.2200 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

Yes

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Liquid-crystal patient thermometer, single-use

TempAlert II by Lcr Hallcrest, Llc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Liquid-crystal patient thermometer, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Lcr Hallcrest, Llc.

Sources (1)

  • FDA UDI 69f661cb-12d9-4011-9faf-abbe555be45e 36 fields · synced May 30, 2026