Performer HT

Basic Information

• Brand Name: Performer HT
• Primary DI: M640R51000710041
• Version / Model: 004
• Catalog Number: R5100071
• Company Name: RAND SPA
• Labeler DUNS: 655010531
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-04-27
• Public Version: 1
• Public Version Date: 2020-05-05
• Public Version Status: New
• Public Device Record Key: 6dbf7c23-9781-405b-902d-65e8fcd00d0c

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LGZ	Warmer, Thermal, Infusion Fluid	General Hospital	880.5725	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47760	Intravascular/intracavitary-circulation hyperthermia system	An assembly of devices designed to circulate warmed fluids or autologous blood through the vasculature or cavity of a targeted anatomical area (e.g., peritoneal/pleural cavities, thorax, abdomen, section of a limb) to treat cancer. Blood/fluids (may include drugs) are warmed and circulated by the system's extracorporeal circuit. It is typically computer-controlled and consists of pumps, heat exchanger, valves, detectors/sensors, clamps, monitors, alarms, disposable tubing/filtration set and oxygenator. It heats the blood/fluids to temperatures up to 43° C to enhance the effect of drugs [e.g., for intraperitoneal hyperthermic chemotherapy (IPHC)] and help destroy cancer cells.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M640R51000710041	HIBCC

Premarket Submissions

Submission Number	Supplement Number
K120026	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -20 – 60 Degrees Celsius
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 700 – 1060 millibar
• Type: Storage Environment Humidity
• Temperature Range: 10 – 90 Percent (%) Relative Humidity