InfraRX

GUDID 00183470000746

Thermotex Therapy Systems Ltd.

Musculoskeletal infrared phototherapy unit, non-wearable

• Primary Device ID: 00183470000746
• NIH Device Record Key: 3b1a3689-aca1-4d78-ac05-739da828807e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: InfraRX
• Version Model Number: Neck
• Company DUNS: 203727354
• Company Name: Thermotex Therapy Systems Ltd.
• 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: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00183470000746 [Primary]

FDA Product Code

• IRT: Pad, Heating, 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: 2023-10-02
• Device Publish Date: 2023-09-24

On-Brand Devices [InfraRX]

• 00183470000760: Foot
• 00183470000746: Neck
• 00183470000715: Platinum