BSD-500 Hyperthermia System

GUDID 00864445000434

The BSD-500 Hyperthermia System delivers therapeutic heat to certain surface or subsurface malignant tumors by the external or interstitial application of electromagnetic energy and monitors the temperature of target and surrounding tissues by means of independent temperature sensors.

Pyrexar Medical Inc.

Microwave hyperthermia system

• Primary Device ID: 00864445000434
• NIH Device Record Key: 3667631c-9e05-4a3e-ae17-ef299d1c7432
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BSD-500 Hyperthermia System
• Version Model Number: BSD-500
• 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

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00864445000434 [Primary]
GS1	08644450004342 [Previous]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P820088

FDA Product Code

• LOC: System, Rf/Microwave Hyperthermia, 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-500 Hyperthermia System]

• 08644450004342: The BSD-500 Hyperthermia System delivers therapeutic heat to certain surface or subsurface malig
• 00864445000434: The BSD-500 Hyperthermia System delivers therapeutic heat to certain surface or subsurface malig