Compumedics SynAmps RT 9021-0002-01

GUDID 09342451001504

Package, System Unit - SynAmps RT + IMECSU-2

COMPUMEDICS LIMITED

Electroencephalograph
Primary Device ID09342451001504
NIH Device Record Key861fff70-b2b3-4b9f-8d57-ba650de482a9
Commercial Distribution StatusIn Commercial Distribution
Brand NameCompumedics SynAmps RT
Version Model NumberSynAmps RT
Catalog Number9021-0002-01
Company DUNS753750967
Company NameCOMPUMEDICS LIMITED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-877-294-1346
Emailsupport@compumedicsusa.com
Phone1-877-294-1346
Emailsupport@compumedicsusa.com
Phone1-877-294-1346
Emailsupport@compumedicsusa.com
Phone1-877-294-1346
Emailsupport@compumedicsusa.com
Phone1-877-294-1346
Emailsupport@compumedicsusa.com
Phone1-877-294-1346
Emailsupport@compumedicsusa.com
Phone1-877-294-1346
Emailsupport@compumedicsusa.com
Phone1-877-294-1346
Emailsupport@compumedicsusa.com
Phone1-877-294-1346
Emailsupport@compumedicsusa.com
Phone1-877-294-1346
Emailsupport@compumedicsusa.com
Phone1-877-294-1346
Emailsupport@compumedicsusa.com
Phone1-877-294-1346
Emailsupport@compumedicsusa.com
Phone1-877-294-1346
Emailsupport@compumedicsusa.com
Phone1-877-294-1346
Emailsupport@compumedicsusa.com
Phone1-877-294-1346
Emailsupport@compumedicsusa.com
Phone1-877-294-1346
Emailsupport@compumedicsusa.com
Phone1-877-294-1346
Emailsupport@compumedicsusa.com
Phone1-877-294-1346
Emailsupport@compumedicsusa.com
Phone1-877-294-1346
Emailsupport@compumedicsusa.com
Phone1-877-294-1346
Emailsupport@compumedicsusa.com
Phone1-877-294-1346
Emailsupport@compumedicsusa.com
Phone1-877-294-1346
Emailsupport@compumedicsusa.com
Phone1-877-294-1346
Emailsupport@compumedicsusa.com
Phone1-877-294-1346
Emailsupport@compumedicsusa.com
Phone1-877-294-1346
Emailsupport@compumedicsusa.com
Phone1-877-294-1346
Emailsupport@compumedicsusa.com

Operating and Storage Conditions

Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
Storage Environment TemperatureBetween -20 Degrees Celsius and 70 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS109342451001504 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GWQFull-Montage Standard Electroencephalograph

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2021-04-27
Device Publish Date2016-11-17

On-Brand Devices [Compumedics SynAmps RT]

09342451001580Assembly, SynAmps RT System Unit
09342451001573Package, System Unit - SynAmps RT
09342451001566Assembly, SynAmps RT, 64-Channel Headbox
09342451001559Package, Headbox - SynAmps RT 64-Channel
09342451001542Assembly, SynAmps RT Power Unit
09342451001535Package, Power Unit - SynAmps RT
09342451001528SynAmps RT system module + IMECSU-2
09342451001511Cable Assy - Deblock/MR Interface - SynAmps2
09342451001504Package, System Unit - SynAmps RT + IMECSU-2

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