AccessGUDID - DEVICE: BSD-2000 Hyperthermia System (00851551005170)

GUDID

Device Identifier (DI) Information

Brand Name: BSD-2000 Hyperthermia System
Version or Model: BSD-2000B
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: BSD MEDICAL CORPORATION

Primary DI Number: 00851551005170
Issuing Agency: GS1
Commercial Distribution End Date: April 01, 2015
Device Count: 1
Labeler D-U-N-S® Number*: 089326938 *Terms of Use

Device Description: Deep Hyperthermia System (U.S.A.)

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PAS	RF/Microwave hyperthermia system, cancer treatment

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between -15 and 40 Degrees Celsius
Storage Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Handling Environment Temperature: between -15 and 40 Degrees Celsius
Handling Environment Humidity: between 10 and 90 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e93a1c4b-8ea8-4589-8d96-28263f9f7bef
Public Version Date: May 29, 2023
Public Version Number: 3
DI Record Publish Date: September 24, 2014