BSD-2000 Hyperthermia System

Basic Information

• Brand Name: BSD-2000 Hyperthermia System
• Primary DI: 00851551005187
• Version / Model: BSD-2000U
• Company Name: BSD MEDICAL CORPORATION
• Labeler DUNS: 089326938
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-09-24
• Public Version: 3
• Public Version Date: 2023-05-29
• Public Version Status: Update
• Public Device Record Key: 8f1a24c8-6998-4366-8f66-297ed28f3efc
• Distribution End Date: 2015-04-01

Device Description

Deep Hyperthermia System (U.S.A.)

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PAS	RF/Microwave hyperthermia system, cancer treatment	Unknown		f

GMDN Terms

Code	Name	Definition	Implantable	Status
40782	Tumour-therapy radio-frequency hyperthermia system	A 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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00851551005187	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -15 – 40 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: 10 – 90 Percent (%) Relative Humidity
• Type: Storage Environment Humidity
• Temperature Range: 10 – 90 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: -15 – 40 Degrees Celsius