FDA.reportPublic FDA data

Performer HT

Primary DI
M640R51000710041
Brand
Performer HT
Company
RAND SPA
Model
004
Catalog number
R5100071
Published
2020-04-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LGZWarmer, Thermal, Infusion Fluid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LGZWarmer, Thermal, Infusion FluidGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K120026000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K120026000PERFORMER HT/ HANG&GO HT BASICRand S.R.L.2012-05-08LGZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M640R51000710041PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Intravascular/intracavitary-circulation hyperthermia systemAn 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure700 millibar1060 millibar
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
655010531
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M640R99001200051Hang&Go005R99001202023-11-28
M640R99001170031Hang&Go PAC003R99001172022-06-22
M640R99000990011Ch24 round silicone catheter001R99000992020-04-20
M640R99001170021Hang&Go PAC002R99001172021-02-12
M640R99000900011Hang&Go HT Basic 001R99000902020-07-23
M640R99001170011Hang&Go PAC001R99001172020-07-23
M640R99001200021Hang&Go002R99001202020-07-23
M640R99001200031Hang&Go003R99001202020-07-23
M640R99000990001Ch24 round silicone catheter000R99000992017-01-27
M640R99000900021Hang&Go HT Basic 002R99000902021-02-12
M640R99001200041Hang&Go004R99001202021-02-12
M640R99001200011Hang&Go001R99001202020-04-27
M640R99000900001Hang&Go HT Basic 000R99000902017-01-27
M640R99001170001Hang&Go PAC000R99001172017-02-21
M640R99000990012Ch24 round silicone catheter001R99000992020-04-20
M640R51000710031Performer HT003R51000712018-09-07
M640R99001200001Hang&Go000R99001202017-01-09
M640R51000710001Performer HT000R51000712017-01-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841027104766Pedigo Products, Inc.PEDIGO PRODUCTS, INC.LGZ2026-06-02
00841027104728Pedigo Products, Inc.PEDIGO PRODUCTS, INC.LGZ2026-05-12
00841027104735Pedigo Products, Inc.PEDIGO PRODUCTS, INC.LGZ2026-05-12
00841027104742Pedigo Products, Inc.PEDIGO PRODUCTS, INC.LGZ2026-05-12
00841027104759Pedigo Products, Inc.PEDIGO PRODUCTS, INC.LGZ2026-05-12
07540162042867HugAire 2 Cu.Ft.Single Compartment Warming CabinetImperial Surgical LtdLGZ2026-04-24
00724995153724AmscoSTERIS CORPORATIONLGZ2026-02-13
00724995153731AmscoSTERIS CORPORATIONLGZ2026-02-13
00724995153748AmscoSTERIS CORPORATIONLGZ2026-02-13
00724995153755AmscoSTERIS CORPORATIONLGZ2026-02-13
00724995153762AmscoSTERIS CORPORATIONLGZ2026-02-13
00724995153786AmscoSTERIS CORPORATIONLGZ2026-02-13
00724995153793AmscoSTERIS CORPORATIONLGZ2026-02-13
00724995153809AmscoSTERIS CORPORATIONLGZ2026-02-13
00724995154165AmscoSTERIS CORPORATIONLGZ2026-02-13
00724995158422AmscoSTERIS CORPORATIONLGZ2026-02-13
00841027101604Pedigo Products, Inc.PEDIGO PRODUCTS, INC.LGZ2025-12-08
00841027102298Pedigo Products, Inc.PEDIGO PRODUCTS, INC.LGZ2025-12-08
00841027102311Pedigo Products, Inc.PEDIGO PRODUCTS, INC.LGZ2025-12-08
00841027102328Pedigo Products, Inc.PEDIGO PRODUCTS, INC.LGZ2025-12-08
00841027102335Pedigo Products, Inc.PEDIGO PRODUCTS, INC.LGZ2025-12-08
00841027102342Pedigo Products, Inc.PEDIGO PRODUCTS, INC.LGZ2025-12-08
00841027102359Pedigo Products, Inc.PEDIGO PRODUCTS, INC.LGZ2025-12-08
00841027102366Pedigo Products, Inc.PEDIGO PRODUCTS, INC.LGZ2025-12-08
00841027102373Pedigo Products, Inc.PEDIGO PRODUCTS, INC.LGZ2025-12-08
00841027102380Pedigo Products, Inc.PEDIGO PRODUCTS, INC.LGZ2025-12-08
00841027102397Pedigo Products, Inc.PEDIGO PRODUCTS, INC.LGZ2025-12-08
00841027102403Pedigo Products, Inc.PEDIGO PRODUCTS, INC.LGZ2025-12-08
00841027102410Pedigo Products, Inc.PEDIGO PRODUCTS, INC.LGZ2025-12-08
00841027102427Pedigo Products, Inc.PEDIGO PRODUCTS, INC.LGZ2025-12-08