Performer HT R5100071

GUDID M640R51000710041

RAND SPA

Intravascular/intracavitary-circulation hyperthermia system

• Primary Device ID: M640R51000710041
• NIH Device Record Key: 6dbf7c23-9781-405b-902d-65e8fcd00d0c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Performer HT
• Version Model Number: 004
• Catalog Number: R5100071
• Company DUNS: 655010531
• Company Name: RAND SPA
• 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

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	M640R51000710041 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120026

FDA Product Code

• LGZ: Warmer, Thermal, Infusion Fluid

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: 2020-05-05
• Device Publish Date: 2020-04-27

On-Brand Devices [Performer HT]

• M640R51000710031: 003
• M640R51000710001: 000
• M640R51000710041: 004