Titronics

Basic Information

• Brand Name: Titronics
• Primary DI: 00860447001714
• Version / Model: Tytron C-7000
• Company Name: TITRONICS RESEARCH & DEVELOPMENT COMPANY
• Labeler DUNS: 073499345
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-01-21
• Public Version: 1
• Public Version Date: 2019-02-21
• Public Version Status: New
• Public Device Record Key: 8e670d2c-e071-4609-bd0d-d30dc87f1688

Device Description

The C-7000 is indicated for use in detecting, measuring, recording, and graphing the skin surface temperature on both sides of the spine of adults and children by chiropractors. It is to be used before and after therapy is rendered as part of monitoring the patient's response to care, similar to a common thermometer

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• 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
HCS	Device, Temperature Measurement, Direct Contact, Powered	Neurology	882.1570	2

GMDN Terms

Code	Name	Definition	Implantable	Status
36731	Thermographic camera	A camera intended to measure and display differences in temperature, usually shown by colour differences, in humans or objects. Differences in temperature may be used for examination and diagnosis applications (e.g., in skin conditions, vascular disorders, or breast malignancies). This device may be stand-alone or part of a thermographic system.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860447001714	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K974208	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -40 – 50 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 0 – 90 Percent (%) Relative Humidity
• Type: Handling Environment Humidity
• Temperature Range: 0 – 60 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: 21 – 25 Degrees Celsius
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 700 – 1025 millibar
• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 700 – 1025 millibar