BSD-2000 Hyperthermia System

Primary DI
08644450004106
Brand
BSD-2000 Hyperthermia System
Company
Pyrexar Medical Inc.
Model
BSD-2000U
Device description
The BSD-2000 system is a prescription device that is intended to deliver hyperthermia, which has been shown to increase the sensitivity of tumor cells to radiation or chemotherapy by the external application of electromagnetic energy. The system provides hyperthermia to solid tumors by generating and applying radio frequency (RF) energy.
Published
2023-05-24
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
H090002000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
H090002000

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851551005187PreviousGS10
08644450004106PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851551005187008515510051878515510051870851551005187
08644450004106086444500041068644450004106

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
Storage Environment Humidity10 Percent (%) Relative Humidity90 Percent (%) Relative Humidity

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(844)797-3927regulatory@pyrexar.com

Regulatory Flags#

DUNS number
079797900
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00864445000403BSD-2000 Hyperthermia SystemBSD-2000B2023-07-18
00864445000434BSD-500 Hyperthermia SystemBSD-5002023-07-18
00864445000441BSD-2000 Hyperthermia SystemBSD-2000U2023-07-18
08644450004038BSD-2000 Hyperthermia SystemBSD-2000B2023-05-24
08644450004342BSD-500 Hyperthermia SystemBSD-5002023-05-24

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
00851551005170BSD-2000 Hyperthermia SystemBSD MEDICAL CORPORATIONPAS2014-09-24
00851551005187BSD-2000 Hyperthermia SystemBSD MEDICAL CORPORATIONPAS2014-09-24