CorTemp

Basic Information

• Brand Name: CorTemp
• Primary DI: 00857414006001
• Version / Model: HT150002
• Company Name: H Q, INC
• Labeler DUNS: 185719606
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-02-28
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: f99fa2c1-4e38-4eab-ac5b-5d1c41be0a87

Device Description

A small capsule shaped sensor which contains an electronic thermometer. The sensor operates at 262 kHz frequency and transmits via near field magnetic link.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FLL	Thermometer, Electronic, Clinical	General Hospital	880.2910	2

GMDN Terms

Code	Name	Definition	Implantable	Status
55824	Temperature telemetric monitoring system transmitter	A body-worn, battery-powered component of a temperature telemetric monitoring system designed to continuously measure and wirelessly transmit core and/or skin temperature signals to the system's receiver. It typically consists of a portable radio transmitter to which are attached skin, tympanic, rectal, oesophageal, and/or ingestible temperature sensors. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00857414006001	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K880639	000