CorTemp

Basic Information

• Brand Name: CorTemp
• Primary DI: 00857414006049
• Version / Model: HT150001L
• Company Name: H Q, INC
• Labeler DUNS: 185719606
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-04-02
• Public Version: 1
• Public Version Date: 2019-04-10
• Public Version Status: New
• Public Device Record Key: 0290d365-ff6f-4c33-910b-2d92ecc44fd5

Device Description

Lease Handheld electronic device which receives temperature sensitive crystal oscillations via near field magnetic link. The oscillation measurement is converted to a temperature using the sensor's calibration number.

Device Characteristics

• Single Use: No
• 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: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• 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	00857414006049	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K880639	000