Thermidas ThIR-A615

GUDID 06429810718006

Thermidas IR System is a thermal imaging system for measuring and monitoring changes in skin surface temperature non-invasively. The mobile cart-based solution allows capture of thermal images. With its built-in software the solution supports capture, analyzis and storage the image data with minimum effort.

TherMidas Oy

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• Primary Device ID: 06429810718006
• NIH Device Record Key: d534855c-9776-4546-aff0-49f5dac195c7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Thermidas
• Version Model Number: Thermidas IR System
• Catalog Number: ThIR-A615
• Company DUNS: 540505042
• Company Name: TherMidas Oy
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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: +358403520400
• Email: juha.hamalainen@thermidas.fi
• Phone: +358403520400
• Email: juha.hamalainen@thermidas.fi
• Phone: +358403520400
• Email: juha.hamalainen@thermidas.fi
• Phone: +358403520400
• Email: juha.hamalainen@thermidas.fi
• Phone: +358403520400
• Email: juha.hamalainen@thermidas.fi
• Phone: +358403520400
• Email: juha.hamalainen@thermidas.fi
• Phone: +358403520400
• Email: juha.hamalainen@thermidas.fi
• Phone: +358403520400
• Email: juha.hamalainen@thermidas.fi
• Phone: +358403520400
• Email: juha.hamalainen@thermidas.fi
• Phone: +358403520400
• Email: juha.hamalainen@thermidas.fi
• Phone: +358403520400
• Email: juha.hamalainen@thermidas.fi
• Phone: +358403520400
• Email: juha.hamalainen@thermidas.fi
• Phone: +358403520400
• Email: juha.hamalainen@thermidas.fi
• Phone: +358403520400
• Email: juha.hamalainen@thermidas.fi
• Phone: +358403520400
• Email: juha.hamalainen@thermidas.fi
• Phone: +358403520400
• Email: juha.hamalainen@thermidas.fi
• Phone: +358403520400
• Email: juha.hamalainen@thermidas.fi
• Phone: +358403520400
• Email: juha.hamalainen@thermidas.fi

Device Identifiers

Device Issuing Agency	Device ID
GS1	06429810718006 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200999

FDA Product Code

• LHQ: System, Telethermographic (Adjunctive Use)

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: 2023-08-10
• Device Publish Date: 2023-08-02

On-Brand Devices [Thermidas]

• 06429810718006: Thermidas IR System is a thermal imaging system for measuring and monitoring changes in skin sur
• 06429810718020: Thermidas IRT-384 Camera is a handheld thermal imaging system for measuring and monitoring chang
• 06429810718013: The optional Thermidas Remote SW can be integrated with Thermidas IR System, Thermidas IRT-384 C