FDA.reportPublic FDA data

BSD-2000 Hyperthermia System

Primary DI
00851551005170
Brand
BSD-2000 Hyperthermia System
Company
BSD MEDICAL CORPORATION
Model
BSD-2000B
Device description
Deep 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
PASRF/Microwave hyperthermia system, cancer treatment

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PASRf/Microwave Hyperthermia System, Cancer TreatmentUnknownf

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851551005170PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851551005170008515510051708515510051700851551005170

GMDN Terms#

Term, Definition table
TermDefinition
Tumour-therapy radio-frequency hyperthermia systemA mains electricity (AC-powered) device assembly designed for controlled heating (i.e., temperatures around 43° Celsius) of the body using radio-frequency (RF) energy, for the treatment of malignant or benign tumours, or other disease conditions; it is not intended for direct tissue ablation. It includes an RF generator, controls, software and an RF 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
00851551005187BSD-2000 Hyperthermia SystemBSD-2000U2014-09-24
00851551005194BSD-500 Hyperthermia SystemBSD-5002014-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00864445000403BSD-2000 Hyperthermia SystemPyrexar Medical Inc.PAS2023-07-18
00864445000441BSD-2000 Hyperthermia SystemPyrexar Medical Inc.PAS2023-07-18
08644450004038BSD-2000 Hyperthermia SystemPyrexar Medical Inc.PAS2023-05-24
08644450004106BSD-2000 Hyperthermia SystemPyrexar Medical Inc.PAS2023-05-24
00851551005187BSD-2000 Hyperthermia SystemBSD MEDICAL CORPORATIONPAS2014-09-24