FDA.reportPublic FDA data

Quantum ®

Primary DI
05060434420749
Brand
Quantum ®
Company
SPECTRUM MEDICAL LIMITED
Model
QPF1
Catalog number
51-000024-00
Device description
Quantum Pump Frame 1 - Blackpool
Published
2018-06-01
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DTQConsole, Heart-Lung Machine, Cardiopulmonary Bypass

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DTQConsole, Heart-Lung Machine, Cardiopulmonary BypassCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K173834000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173834000Quantum Pump ConsoleSpectrum Medical , Ltd.2018-05-25DTQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060434420749PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060434420749050604344207495060434420749

GMDN Terms#

Term, Definition table
TermDefinition
Extracorporeal blood gas/pH monitorA mains electricity (AC-powered) device designed for the continuous measurement and display of blood gas and related parameters when blood is circulated outside of the body in a closed system. It is typically used with an appropriate sensor or sensor cassette inserted into external tubing to measure parameters such as partial pressure of oxygen (pO2), partial pressure of carbon dioxide (pCO2), pH, temperature, haemoglobin (Hb), and hematocrit (Hct). It is typically used with a cardiopulmonary bypass system, or bedside for a patient with respiratory failure (e.g., obstructive lung disease, severe asthma) or severe pulmonary hypertension after cardiac surgery.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure76 KiloPascal106 KiloPascal
Handling Environment Humidity0 Percent (%) Relative Humidity90 Percent (%) Relative Humidity
Handling Environment Temperature0 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800 265 2331ussales@spectrummedical.com
+441242650120eusales@spectrummedical.com

Regulatory Flags#

DUNS number
516398679
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060434424457QuantumQPF851-000162-002026-03-20
05060434422309QuantumQWS12E51-000094-002020-10-05
05060434423016QuantumHBS1-05051-000123-002023-04-10
05060434422293QuantumQWS15S51-000093-002022-01-12
05060434422231QuantumQPR251-000088-002019-11-21
05060434422354QuantumQPR351-000097-002019-11-21
05060434423436QuantumQSOL51-000022-012021-04-05
05060434423443QuantumQSOR51-000074-012021-04-05
05060434422262QuantumQPF551-000090-002020-04-14
05060434422316QuantumQPF651-000095-002020-04-14
05060434422026QuantumQWSL51-000080-002019-07-10
05060434420732QuantumQSOL51-000022-002019-06-20
05060434421944QuantumQSOR51-000074-002019-06-20
05060434420008QuantumQWS51-000001-002017-01-24
05060434420688QuantumQVM51-000045-002019-01-14
05060434420718Quantum ®QWS1251-000031-002019-01-14
05060434420756Quantum ®QPF251-000025-002018-06-01
05060434420824QuantumQPF351-000056-002018-06-01
05060434420886QuantumQPR143-0009182018-05-31
05060434420954QuantumQPF451-000059-002018-06-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04033817904137DeviceLivaNova Deutschland GmbHDTQ2026-01-22
04033817904144DeviceLivaNova Deutschland GmbHDTQ2026-01-22
04033817901693Virtual Kit NumberLivaNova Deutschland GmbHDTQ2024-07-23
05060434424044QuantumSPECTRUM MEDICAL LIMITEDDTQ2024-02-27
05060434424051Quantum SPECTRUM MEDICAL LIMITEDDTQ2024-02-27
04033817903017ESSENZLivaNova Deutschland GmbHDTQ2024-02-22
00886799002056Terumo® Advanced Perfusion System 1Terumo Cardiovascular Systems CorporationDTQ2023-11-03
00886799002063Terumo® Advanced Perfusion System 1Terumo Cardiovascular Systems CorporationDTQ2023-11-03
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00886799002087Terumo® Advanced Perfusion System 1Terumo Cardiovascular Systems CorporationDTQ2023-11-03
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00886799001837Terumo® Advanced Perfusion System 1Terumo Cardiovascular Systems CorporationDTQ2023-06-20
00886799001844Terumo® Advanced Perfusion System 1Terumo Cardiovascular Systems CorporationDTQ2023-06-20
00886799001820Terumo® Advanced Perfusion System 1Terumo Cardiovascular Systems CorporationDTQ2023-05-24
00886799001813Terumo® Advanced Perfusion System 1Terumo Cardiovascular Systems CorporationDTQ2023-05-18
05415067036414CentriMag™Thoratec CorporationDTQ2023-05-17
04033817902423AccessoriesLivaNova Deutschland GmbHDTQ2023-03-21
04033817902430AccessoriesLivaNova Deutschland GmbHDTQ2023-03-21
04033817902447AccessoriesLivaNova Deutschland GmbHDTQ2023-03-21
04033817902454AccessoriesLivaNova Deutschland GmbHDTQ2023-03-21
04033817902461AccessoriesLivaNova Deutschland GmbHDTQ2023-03-21
04033817902478AccessoriesLivaNova Deutschland GmbHDTQ2023-03-21
04033817902485AccessoriesLivaNova Deutschland GmbHDTQ2023-03-21
04033817902492AccessoriesLivaNova Deutschland GmbHDTQ2023-03-21
04033817902997ESSENZLivaNova Deutschland GmbHDTQ2023-03-21
04033817903024ESSENZLivaNova Deutschland GmbHDTQ2023-03-21
04033817903031ESSENZLivaNova Deutschland GmbHDTQ2023-03-21
04033817903048ESSENZLivaNova Deutschland GmbHDTQ2023-03-21
04033817903055ESSENZLivaNova Deutschland GmbHDTQ2023-03-21
04033817903062ESSENZLivaNova Deutschland GmbHDTQ2023-03-21