Home GUDID 00851551005194
BSD-500 Hyperthermia System
Primary DI 00851551005194
Brand BSD-500 Hyperthermia System
Company BSD MEDICAL CORPORATION
Model BSD-500
Device description Local Hyperthermia System (U.S.A.)
Published 2014-09-24
Public version status Update
Distribution status Not in Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Product Codes# Code, Name table Code Name LOC System, rf/microwave hyperthermia, cancer treatment
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class LOC System, Rf/Microwave Hyperthermia, Cancer Treatment Unknown 3
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00851551005194 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00851551005194 00851551005194 851551005194 0851551005194
GMDN Terms# Term, Definition table Term Definition Microwave hyperthermia system A mains electricity (AC-powered) device assembly designed for controlled heating (i.e., temperatures above 43° Celsius) of the body using microwaves, for the treatment of malignant or benign tumours or other disease conditions [e.g., benign prostatic hyperplasia (BPH), prostatitis]. It includes a microwave generator, controls, software (e.g., treatment planning software) and a microwave applicator. It is intended for both whole-body and localized heating of tissues/organs through either externally-mounted components or from catheter- or probe-type applicators inserted topically, endoscopically, or surgically.
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Humidity 10 Percent (%) Relative Humidity 90 Percent (%) Relative Humidity Handling Environment Temperature -15 Degrees Celsius 40 Degrees Celsius Storage Environment Humidity 10 Percent (%) Relative Humidity 90 Percent (%) Relative Humidity Storage Environment Temperature -15 Degrees Celsius 40 Degrees Celsius
Regulatory Flags# DUNS number 089326938 Device count 1 Serial number true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 00851551005170 BSD-2000 Hyperthermia System BSD-2000B 2014-09-24 00851551005187 BSD-2000 Hyperthermia System BSD-2000U 2014-09-24
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00864445000434 BSD-500 Hyperthermia System Pyrexar Medical Inc. LOC 2023-07-18 08644450004342 BSD-500 Hyperthermia System Pyrexar Medical Inc. LOC 2023-05-24 06971591765675 Selethru NC PTCA Balloon Dilatation Catheter Kossel Medtech (Suzhou) Co., Ltd. LOC 2021-09-20