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

Contact Domains#

Product Codes#

Code, Name table
CodeName
LOCSystem, rf/microwave hyperthermia, cancer treatment

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LOCSystem, Rf/Microwave Hyperthermia, Cancer TreatmentUnknown3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851551005194PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851551005194008515510051948515510051940851551005194

GMDN Terms#

Term, Definition table
TermDefinition
Microwave hyperthermia systemA 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
TypeLowHighCondition
Handling Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature-15 Degrees Celsius40 Degrees Celsius
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Storage Environment Temperature-15 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(888)444-5737support@bsdmc.com

Regulatory Flags#

DUNS number
089326938
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851551005170BSD-2000 Hyperthermia SystemBSD-2000B2014-09-24
00851551005187BSD-2000 Hyperthermia SystemBSD-2000U2014-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00864445000434BSD-500 Hyperthermia SystemPyrexar Medical Inc.LOC2023-07-18
08644450004342BSD-500 Hyperthermia SystemPyrexar Medical Inc.LOC2023-05-24
06971591765675Selethru NC PTCA Balloon Dilatation CatheterKossel Medtech (Suzhou) Co., Ltd.LOC2021-09-20