Quantum 51-000095-00

GUDID 05060434422316

SPECTRUM MEDICAL LIMITED

Cardiopulmonary bypass system roller pump Cardiopulmonary bypass system roller pump Cardiopulmonary bypass system roller pump Cardiopulmonary bypass system roller pump Cardiopulmonary bypass system roller pump Cardiopulmonary bypass system roller pump Cardiopulmonary bypass system roller pump Cardiopulmonary bypass system roller pump Cardiopulmonary bypass system roller pump Cardiopulmonary bypass system roller pump Cardiopulmonary bypass system roller pump Cardiopulmonary bypass system roller pump Cardiopulmonary bypass system roller pump Cardiopulmonary bypass system roller pump Cardiopulmonary bypass system roller pump Cardiopulmonary bypass system roller pump
Primary Device ID05060434422316
NIH Device Record Key7326f5e2-a9fa-4c34-9a59-9c38e9826d39
Commercial Distribution StatusIn Commercial Distribution
Brand NameQuantum
Version Model NumberQuantum Pump Frame 6 - Toronto (QPF6)
Catalog Number51-000095-00
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 Batchtrue
Serial Numberfalse
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

Phone+441242650120
Emaileusales@spectrummedical.com
Phone+441242650120
Emaileusales@spectrummedical.com
Phone+441242650120
Emaileusales@spectrummedical.com
Phone+441242650120
Emaileusales@spectrummedical.com
Phone+441242650120
Emaileusales@spectrummedical.com
Phone+441242650120
Emaileusales@spectrummedical.com
Phone+441242650120
Emaileusales@spectrummedical.com
Phone+441242650120
Emaileusales@spectrummedical.com
Phone+441242650120
Emaileusales@spectrummedical.com
Phone+441242650120
Emaileusales@spectrummedical.com
Phone+441242650120
Emaileusales@spectrummedical.com
Phone+441242650120
Emaileusales@spectrummedical.com
Phone+441242650120
Emaileusales@spectrummedical.com
Phone+441242650120
Emaileusales@spectrummedical.com
Phone+441242650120
Emaileusales@spectrummedical.com
Phone+441242650120
Emaileusales@spectrummedical.com

Operating and Storage Conditions

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
Handling Environment Atmospheric PressureBetween 76 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing AgencyDevice ID
GS105060434422316 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DTQConsole, Heart-Lung Machine, Cardiopulmonary Bypass

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-04-22
Device Publish Date2020-04-14

On-Brand Devices [Quantum]

05060434420879Quantum Anesthetic Gas Sensor (QAN1)
05060434421944Quantum Smart Occluder - Right Hand (QSOR)
05060434420732Quantum Smart Occluder - Left hand (QSOL)
05060434422125ID 1/2" x Wall 3/32" (OD 11/16") 3.0m
05060434422118ID 3/8" x Wall 3/32" (OD 9/16") 3.0m
05060434422101ID 1/4" x Wall 3/32" (OD 7/16") 3.0m
05060434422095ID 1/4" x Wall 1/16" (OD 3/8") 3.0m
05060434422088ID 3/16" x Wall 1/16" (OD 5/16") 3.0m
05060434422019ID 1/2" x Wall 3/32"(OD11/16") 0.75m
05060434422002ID 3/8" x Wall 3/32" (OD 9/16") 0.75m
05060434421999ID 1/4" x Wall 3/32" (OD 7/16") 0.75m
05060434421982ID 1/4" x Wall 1/16" (OD 3/8") 0.75m
05060434421975ID 3/16" x Wall 1/16" (OD 5/16") 0.75m
05060434421883ID 1/2" x Wall 3/32" (OD 11/16") 2.0m
05060434421876ID 3/8" x Wall 3/32" (OD 9/16") 2.0m
05060434421869ID 1/4" x Wall 3/32" (OD 7/16") 2.0m
05060434421852ID 1/4" x Wall 1/16" (OD 3/8") 2.0m
05060434421845ID 3/16" x Wall 1/16" (OD 5/16") 2.0m
05060434422026Quantum Workstation Lite (QWSL)
05060434422316Quantum Pump Frame 6 - Toronto (QPF6)
05060434422262Quantum Pump Frame 5 - Charlotte (QPF5)
05060434421838Quantum Centrifugal Drive High Pressure (QCD37)
05060434421821Quantum Centrifugal Drive Medium Pressure (QCD22)
05060434422972Quantum Flow Sensor - ID 1/2" x Wall 3/32" (OD 11/16") 1.5m (QF25) Right Angled
05060434422965Quantum Flow Sensor - ID 3/8" x Wall 3/32" (OD 9/16") 1.5m (QF24) Right Angled
05060434422958Quantum Flow Sensor - ID 1/4" x Wall 3/32" (OD 7/16") 1.5m (QF23) Right Angled
05060434422941Quantum Flow Sensor - ID 1/4" x Wall 1/16" (OD 3/8") 1.5m (QF22) Right Angled
05060434422934Quantum Flow Sensor - ID 3/16" x Wall 1/16" (OD 5/16") 1.5m (QF21)Right Angled
05060434422927Quantum Flow Sensor - ID 1/2" x Wall 3/32" (OD 11/16") 0.6m (QF20) Right Angled
05060434422910Quantum Flow Sensor - ID 3/8" x Wall 3/32" (OD 9/16") 0.6m (QF19) Right Angled
05060434422903Quantum Flow Sensor - ID 1/4" x Wall 3/32" (OD 7/16") 0.6m (QF18) Right Angled
05060434422897Quantum Flow Sensor - ID 1/4" x Wall 1/16" (OD 3/8") 0.6m (QF17) Right Angled
05060434422880Quantum Flow Sensor - ID 3/16" x Wall 1/16" (OD 5/16") 0.6m (QF16) Right Angled
05060434423276Quantum Flow Sensor - ID 1/2" x Wall 3/32" (OD 11/16") 1.2m (QF35)
05060434423269Quantum Flow Sensor - ID 3/8" x Wall 3/32" (OD 9/16") 1.2m (QF34)
05060434423252Quantum Flow Sensor - ID 1/4" x Wall 3/32" (OD 7/16") 1.2m (QF33)
05060434423245Quantum Flow Sensor - ID 1/4" x Wall 1/16" (OD 3/8") 1.2m (QF32)
05060434423238Quantum Flow Sensor - ID 3/16" x Wall 1/16" (OD 5/16") 1.2m (QF31)
05060434423221Quantum Flow Sensor - ID 1/2" x Wall 3/32" (OD 11/16") 0.75m (QF30) Right Angled
05060434423214Quantum Flow Sensor - ID 3/8" x Wall 3/32" (OD 9/16") 0.75m (QF29) Right Angled
05060434423207Quantum Flow Sensor - ID 1/4" x Wall 3/32" (OD 7/16") 0.75m (QF28) Right Angled
05060434423191Quantum Flow Sensor - ID 1/4" x Wall 1/16" (OD 3/8") 0.75m (QF27) Right Angled
05060434423184Quantum Flow Sensor - ID 3/16" x Wall 1/16" (OD 5/16") 0.75m (QF26) Right Angled
05060434422743Quantum Ventilation Module - NIST (Tube Mount)
05060434422736Quantum Ventilation Module - DISS (Tube Mount)
05060434422071Quantum Ventilation Module - DISS (Hook Mount)
05060434422064Quantum Ventilation Module - NIST (Hook Mount)
05060434423443Quantum Smart Occluder - Right Hand
05060434423436Quantum Smart Occluder - Left hand
05060434423122Quantum Pump Frame 5 - Charlotte

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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