BSD-2000 Hyperthermia System

GUDID 00864445000441

The BSD-2000 system is a prescription device that is intended to deliver hyperthermia, which has been shown to increase the sensitivity of tumor cells to radiation or chemotherapy by the external application of electromagnetic energy. The system provides hyperthermia to solid tumors by generating and applying radio frequency (RF) energy.

Pyrexar Medical Inc.

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• Primary Device ID: 00864445000441
• NIH Device Record Key: d0f12851-4807-4e5e-9288-a3a9dbfeaed2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BSD-2000 Hyperthermia System
• Version Model Number: BSD-2000U
• Company DUNS: 079797900
• Company Name: Pyrexar Medical Inc.
• 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: false
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(844)797-3927
• Email: regulatory@pyrexar.com
• Phone: +1(844)797-3927
• Email: regulatory@pyrexar.com
• Phone: +1(844)797-3927
• Email: regulatory@pyrexar.com
• Phone: +1(844)797-3927
• Email: regulatory@pyrexar.com
• Phone: +1(844)797-3927
• Email: regulatory@pyrexar.com
• Phone: +1(844)797-3927
• Email: regulatory@pyrexar.com
• Phone: +1(844)797-3927
• Email: regulatory@pyrexar.com
• Phone: +1(844)797-3927
• Email: regulatory@pyrexar.com
• Phone: +1(844)797-3927
• Email: regulatory@pyrexar.com
• Phone: +1(844)797-3927
• Email: regulatory@pyrexar.com
• Phone: +1(844)797-3927
• Email: regulatory@pyrexar.com
• Phone: +1(844)797-3927
• Email: regulatory@pyrexar.com
• Phone: +1(844)797-3927
• Email: regulatory@pyrexar.com
• Phone: +1(844)797-3927
• Email: regulatory@pyrexar.com
• Phone: +1(844)797-3927
• Email: regulatory@pyrexar.com
• Phone: +1(844)797-3927
• Email: regulatory@pyrexar.com

Operating and Storage Conditions

• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Handling Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	00864445000441 [Primary]
GS1	08644450004106 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• H090002

FDA Product Code

• PAS: Rf/Microwave Hyperthermia System, Cancer Treatment

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: 2023-07-26
• Device Publish Date: 2023-07-18

On-Brand Devices [BSD-2000 Hyperthermia System]

• 08644450004106: The BSD-2000 system is a prescription device that is intended to deliver hyperthermia, which has
• 08644450004038: The BSD-2000 system is a prescription device that is intended to deliver hyperthermia, which has
• 00864445000441: The BSD-2000 system is a prescription device that is intended to deliver hyperthermia, which has
• 00864445000403: The BSD-2000 system is a prescription device that is intended to deliver hyperthermia, which has