Quantum ® 51-000032-00

GUDID 05060434420695

Multi parameter extracorporeal measurment unit - No Gas

SPECTRUM MEDICAL LIMITED

Extracorporeal blood gas/pH monitor Extracorporeal blood gas/pH monitor Extracorporeal blood gas/pH monitor Extracorporeal blood gas/pH monitor Extracorporeal blood gas/pH monitor Extracorporeal blood gas/pH monitor Extracorporeal blood gas/pH monitor Extracorporeal blood gas/pH monitor Extracorporeal blood gas/pH monitor Extracorporeal blood gas/pH monitor Extracorporeal blood gas/pH monitor Extracorporeal blood gas/pH monitor Extracorporeal blood gas/pH monitor Extracorporeal blood gas/pH monitor Extracorporeal blood gas/pH monitor Extracorporeal blood gas/pH monitor
Primary Device ID05060434420695
NIH Device Record Keyb3d87ff7-d47a-4a46-beb6-5fb1d61b88c3
Commercial Distribution StatusIn Commercial Distribution
Brand NameQuantum ®
Version Model NumberQuantum Diagnostic Module - No Gas (QDM2)
Catalog Number51-000032-00
Company DUNS516398679
Company NameSPECTRUM MEDICAL LIMITED
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800 265 2331
Emailussales@spectrummedical.com
Phone800 265 2331
Emailussales@spectrummedical.com
Phone800 265 2331
Emailussales@spectrummedical.com
Phone800 265 2331
Emailussales@spectrummedical.com
Phone800 265 2331
Emailussales@spectrummedical.com
Phone800 265 2331
Emailussales@spectrummedical.com
Phone800 265 2331
Emailussales@spectrummedical.com
Phone800 265 2331
Emailussales@spectrummedical.com
Phone800 265 2331
Emailussales@spectrummedical.com
Phone800 265 2331
Emailussales@spectrummedical.com
Phone800 265 2331
Emailussales@spectrummedical.com
Phone800 265 2331
Emailussales@spectrummedical.com
Phone800 265 2331
Emailussales@spectrummedical.com
Phone800 265 2331
Emailussales@spectrummedical.com
Phone800 265 2331
Emailussales@spectrummedical.com
Phone800 265 2331
Emailussales@spectrummedical.com

Operating and Storage Conditions

Handling Environment Atmospheric PressureBetween 76 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Handling Environment Atmospheric PressureBetween 76 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Handling Environment Atmospheric PressureBetween 76 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Handling Environment Atmospheric PressureBetween 76 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Handling Environment Atmospheric PressureBetween 76 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Handling Environment Atmospheric PressureBetween 76 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Handling Environment Atmospheric PressureBetween 76 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Handling Environment Atmospheric PressureBetween 76 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Handling Environment Atmospheric PressureBetween 76 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Handling Environment Atmospheric PressureBetween 76 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Handling Environment Atmospheric PressureBetween 76 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Handling Environment Atmospheric PressureBetween 76 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Handling Environment Atmospheric PressureBetween 76 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Handling Environment Atmospheric PressureBetween 76 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius
Handling Environment Atmospheric PressureBetween 76 KiloPascal and 106 KiloPascal
Handling Environment HumidityBetween 0 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Handling Environment TemperatureBetween 0 Degrees Celsius and 60 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS105060434420695 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DRYMonitor, Blood-Gas, On-Line, Cardiopulmonary Bypass

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-08-21
Device Publish Date2018-04-05

On-Brand Devices [Quantum ®]

05060434420954Quantum Pump Frame 4 - New York (QPF4)
05060434420893Resevoir Level Sensor
05060434420886Pressure Sensor Assembly
05060434420824Quantum Pump Frame 3 - Vienna (QPF3)
05060434420817Diagnostic Exhaust for use with Quantum Dagnostic Modules
05060434420800Quantum Pump Control Module (QCM)
05060434420794Quantum Roller Pump - 4 inch (QRP4)
05060434420787Quantum Roller Pump - 6 inch (QRP6)
05060434420770Quantum Roller Pump - 8 inch (QRP8)
05060434420763Quantum Power Supply (QPS)
05060434420756Quantum Pump Frame 2 - Cheltenham (QPF2)
05060434420749Quantum Pump Frame 1 - Blackpool (QPF1)
05060434420718Extracorporeal Blood Parameter Monitor
05060434420701EMulti parameter extracorporeal measurment unit
05060434420695Multi parameter extracorporeal measurment unit - No Gas
05060434420688Quantum Ventilation Module (QVM)
05060434420039Quantum Data Management Unit
05060434420008Extracorporeal Blood Parameter Monitor

Trademark Results [Quantum]

Mark Image

Registration | Serial
Company
Trademark
Application Date
QUANTUM
QUANTUM
98424129 not registered Live/Pending
HOUSE X AMERICA LLC
2024-02-27
QUANTUM
QUANTUM
98417725 not registered Live/Pending
Meta Materials Inc.
2024-02-23
QUANTUM
QUANTUM
98388177 not registered Live/Pending
Thomas P. Dakich
2024-02-02
QUANTUM
QUANTUM
98386723 not registered Live/Pending
Kuku, Jalil
2024-02-01
QUANTUM
QUANTUM
98384415 not registered Live/Pending
Starkey Laboratories, Inc.
2024-01-31
QUANTUM
QUANTUM
98362353 not registered Live/Pending
The Upper Deck Company
2024-01-17
QUANTUM
QUANTUM
98276061 not registered Live/Pending
Jayakumar, Philip
2023-11-17
QUANTUM
QUANTUM
98268023 not registered Live/Pending
CREATIVE SYSTEMS AND DESIGN, LLC
2023-11-13
QUANTUM
QUANTUM
98264792 not registered Live/Pending
PPG INDUSTRIES OHIO, INC.
2023-11-10
QUANTUM
QUANTUM
98251741 not registered Live/Pending
SOILSON, JEFFREY A.
2023-11-02
QUANTUM
QUANTUM
98239151 not registered Live/Pending
GEA Farm Technologies, Inc.
2023-10-25
QUANTUM
QUANTUM
98238680 not registered Live/Pending
Cozzia USA, LLC
2023-10-24

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