AccessGUDID - DEVICE: Titronics (00860447001738)

GUDID

Device Identifier (DI) Information

Brand Name: Titronics
Version or Model: C-5000
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: TITRONICS RESEARCH & DEVELOPMENT COMPANY

Primary DI Number: 00860447001738
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 073499345 *Terms of Use

Device Description: 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

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FQZ	Thermometer, Clinical Color Change

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

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

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 111e6b7a-6004-47e2-ae2a-2a0719ab883c
Public Version Date: January 26, 2024
Public Version Number: 1
DI Record Publish Date: January 18, 2024