BSD-2000 Hyperthermia System

GUDID 00851551005187

Deep Hyperthermia System (U.S.A.)

BSD MEDICAL CORPORATION

Tumour-therapy radio-frequency hyperthermia system
Primary Device ID00851551005187
NIH Device Record Key8f1a24c8-6998-4366-8f66-297ed28f3efc
Commercial Distribution StatusIn Commercial Distribution
Brand NameBSD-2000 Hyperthermia System
Version Model NumberBSD-2000U
Company DUNS089326938
Company NameBSD MEDICAL CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(888)444-5737
Emailsupport@bsdmc.com
Phone+1(888)444-5737
Emailsupport@bsdmc.com
Phone+1(888)444-5737
Emailsupport@bsdmc.com
Phone+1(888)444-5737
Emailsupport@bsdmc.com
Phone+1(888)444-5737
Emailsupport@bsdmc.com
Phone+1(888)444-5737
Emailsupport@bsdmc.com
Phone+1(888)444-5737
Emailsupport@bsdmc.com
Phone+1(888)444-5737
Emailsupport@bsdmc.com
Phone+1(888)444-5737
Emailsupport@bsdmc.com
Phone+1(888)444-5737
Emailsupport@bsdmc.com
Phone+1(888)444-5737
Emailsupport@bsdmc.com
Phone+1(888)444-5737
Emailsupport@bsdmc.com
Phone+1(888)444-5737
Emailsupport@bsdmc.com
Phone+1(888)444-5737
Emailsupport@bsdmc.com
Phone+1(888)444-5737
Emailsupport@bsdmc.com
Phone+1(888)444-5737
Emailsupport@bsdmc.com
Phone+1(888)444-5737
Emailsupport@bsdmc.com

Operating and Storage Conditions

Handling Environment TemperatureBetween -15 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween -15 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween -15 Degrees Celsius and 40 Degrees Celsius
Handling Environment TemperatureBetween -15 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -15 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -15 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -15 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -15 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -15 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -15 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -15 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -15 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -15 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -15 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -15 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -15 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -15 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -15 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -15 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -15 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -15 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -15 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -15 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -15 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -15 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -15 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -15 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -15 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -15 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -15 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -15 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -15 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -15 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -15 Degrees Celsius and 40 Degrees Celsius
Storage Environment TemperatureBetween -15 Degrees Celsius and 40 Degrees Celsius
Handling Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween -15 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100851551005187 [Primary]

FDA Product Code

PASRF/Microwave hyperthermia system, cancer treatment

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2014-09-24

On-Brand Devices [BSD-2000 Hyperthermia System]

00851551005187Deep Hyperthermia System (U.S.A.)
00851551005170Deep Hyperthermia System (U.S.A.)

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