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CorTemp

FDA UDI

Class II (US FDA UDI)

by H Q, Inc

Identity

Trade Name
CorTemp FDA UDI
Generic Name
Temperature telemetric monitoring system transmitter FDA UDI
Device Name
A small capsule shaped sensor which contains an electronic thermometer. The sensor operates at 300 kHz frequency and transmits via near field magnetic link.. FDA UDI
Model / Reference
HT150031 FDA UDI
Description
A small capsule shaped sensor which contains an electronic thermometer. The sensor operates at 300 kHz frequency and transmits via near field magnetic link.. FDA UDI

Identifiers

Primary DI / UDI-DI
00857414006018 FDA UDI
510(k) Number
K880639 FDA UDI
FDA Product Code
FLL FDA UDI
GMDN Term
Temperature telemetric monitoring system transmitter 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

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

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

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Temperature telemetric monitoring system transmitter

CorTemp by H Q, Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Temperature telemetric monitoring system transmitter.

Cleared under the same submission

K880639 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
H Q, Inc

Sources (1)

  • FDA UDI e2f12c20-3bda-44c1-8463-41b215711b43 35 fields · synced Jun 8, 2026