AccessGUDID - DEVICE: Thermidas (06429810718013)

GUDID

Device Identifier (DI) Information

Brand Name: Thermidas
Version or Model: Thermidas Remote SW
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ThRemote
Company Name: TherMidas Oy

Primary DI Number: 06429810718013
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 540505042 *Terms of Use

Device Description: The optional Thermidas Remote SW can be integrated with Thermidas IR System, Thermidas IRT-384 Camera, and a set of handheld camera models. The software includes comprehensive set of analysis and reporting tools for both thermal and visual spectrum images. The analyzis tools include adjustment of color scale, use of regions of interest, zoom & pan, and annotations. For reporting purposes, the software includes report generation and image export tools.

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
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?
40803	Infrared thermography system	A system using infrared photography or other infrared detection techniques to produce images or graphical representations of the distribution of body surface temperature for the purpose of diagnosing and assessing various conditions and disease states. Also referred to as a thermography scanner. This system typically consists of a camera display unit that includes a scanning-condensing optical system, infrared detector, an operator's console, photographic cameras, black-body phantom, electronic or computerized controls, software and an image display and analysis units.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LHQ	System, Telethermographic (Adjunctive Use)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K200999	000

Device Exempt from Premarket Submission: No 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 1ba658f0-2dfd-4064-8da2-9ae3acae862a
Public Version Date: August 11, 2023
Public Version Number: 1
DI Record Publish Date: August 03, 2023