Primary Device ID | 00860447001738 |
NIH Device Record Key | 111e6b7a-6004-47e2-ae2a-2a0719ab883c |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Titronics |
Version Model Number | C-5000 |
Company DUNS | 073499345 |
Company Name | TITRONICS RESEARCH & DEVELOPMENT COMPANY |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
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 |
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 |
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 Issuing Agency | Device ID |
---|---|
GS1 | 00860447001738 [Primary] |
FQZ | Thermometer, Clinical Color Change |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-01-26 |
Device Publish Date | 2024-01-18 |
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 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
TITRONICS 88470654 not registered Live/Pending |
TITRONICS RESEARCH & DEVELOPMENT COMPANY 2019-06-12 |