Titronics
GUDID 00860447001707
The C-5000 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
TITRONICS RESEARCH & DEVELOPMENT COMPANY
Thermographic camera Thermographic camera Thermographic camera Thermographic camera Thermographic camera Thermographic camera Thermographic camera Thermographic camera Thermographic camera Thermographic camera Thermographic camera Thermographic camera Thermographic camera Thermographic camera Thermographic camera Thermographic camera Thermographic camera Thermographic camera Thermographic camera| Primary Device ID | 00860447001707 |
| NIH Device Record Key | 3650e39c-ffc5-4372-8c5e-b62bc1fc36cd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Titronics |
| Version Model Number | Tytron C-5000 |
| Company DUNS | 073499345 |
| Company Name | TITRONICS RESEARCH & DEVELOPMENT COMPANY |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | 319-545-7377 |
| chris@titronics.com | |
| Phone | 319-545-7377 |
| chris@titronics.com | |
| Phone | 319-545-7377 |
| chris@titronics.com | |
| Phone | 319-545-7377 |
| chris@titronics.com | |
| Phone | 319-545-7377 |
| chris@titronics.com | |
| Phone | 319-545-7377 |
| chris@titronics.com | |
| Phone | 319-545-7377 |
| chris@titronics.com | |
| Phone | 319-545-7377 |
| chris@titronics.com | |
| Phone | 319-545-7377 |
| chris@titronics.com | |
| Phone | 319-545-7377 |
| chris@titronics.com | |
| Phone | 319-545-7377 |
| chris@titronics.com | |
| Phone | 319-545-7377 |
| chris@titronics.com | |
| Phone | 319-545-7377 |
| chris@titronics.com | |
| Phone | 319-545-7377 |
| chris@titronics.com | |
| Phone | 319-545-7377 |
| chris@titronics.com | |
| Phone | 319-545-7377 |
| chris@titronics.com | |
| Phone | 319-545-7377 |
| chris@titronics.com | |
| Phone | 319-545-7377 |
| chris@titronics.com | |
| Phone | 319-545-7377 |
| chris@titronics.com |
Operating and Storage Conditions
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1025 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1025 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1025 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1025 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1025 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1025 millibar |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 21 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1025 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1025 millibar |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 21 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1025 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1025 millibar |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 21 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1025 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1025 millibar |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 21 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1025 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1025 millibar |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 21 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1025 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1025 millibar |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 21 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1025 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1025 millibar |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 21 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1025 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1025 millibar |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 21 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1025 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1025 millibar |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 21 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1025 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1025 millibar |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 21 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1025 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1025 millibar |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 21 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1025 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1025 millibar |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 21 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1025 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1025 millibar |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 21 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1025 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1025 millibar |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 21 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1025 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1025 millibar |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 21 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1025 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1025 millibar |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 21 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1025 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1025 millibar |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 21 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1025 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1025 millibar |
| Storage Environment Temperature | Between -40 Degrees Celsius and 50 Degrees Celsius |
| Handling Environment Temperature | Between 21 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Humidity | Between 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity |
| Handling Environment Humidity | Between 0 Percent (%) Relative Humidity and 60 Percent (%) Relative Humidity |
| Storage Environment Atmospheric Pressure | Between 700 millibar and 1025 millibar |
| Handling Environment Atmospheric Pressure | Between 700 millibar and 1025 millibar |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00860447001707 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K974208
FDA Product Code
| HCS | Device, Temperature Measurement, Direct Contact, Powered |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-02-21 |
| Device Publish Date | 2019-01-21 |
On-Brand Devices [Titronics]
| 00860447001721 | The Titronics range of motion device is a dual inclinometer system. A goniometer is powered dev |
| 00860447001714 | The C-7000 is indicated for use in detecting, measuring, recording, and graphing the skin surfac |
| 00860447001707 | The C-5000 is indicated for use in detecting, measuring, recording, and graphing the skin surfac |
| 00860447001738 | The C-5000 is indicated for use in detecting, measuring, recording, and graphing the skin surfac |
Trademark Results [Titronics]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TITRONICS 88470654 not registered Live/Pending |
TITRONICS RESEARCH & DEVELOPMENT COMPANY 2019-06-12 |
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