DEVICE: Performer HT (M640R51000710001)

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Device Record History
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Device Identifier (DI) Information
Performer HT
000
Not in Commercial Distribution
R5100071
RAND SPA
M640R51000710001
HIBCC
September 07, 2018
1
655010531 *Terms of Use
No description.
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
No
Yes
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No

GMDN

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GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
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.
Active false
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FDA Product Code

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Product Code Product Code Name
LGZ Warmer, Thermal, Infusion Fluid
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K120026 000
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Sterilization
No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 700 and 1060 millibar
Storage Environment Temperature: between -20 and 60 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status
2a2d0566-91fc-4950-9fed-d4699fa3166a
April 17, 2020
5
January 25, 2017
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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No
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Yes
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Customer Contact

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No Customer Contact currently defined
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