FDA.reportPublic FDA data

Quantum

Primary DI
05060434420831
Brand
Quantum
Company
SPECTRUM MEDICAL LIMITED
Model
QMCDM
Catalog number
51-000014-00
Device description
Quantum Micro-Cardioplegia Delivery Module
Published
2026-02-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DTRHeat-Exchanger, Cardiopulmonary Bypass

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DTRHeat-Exchanger, Cardiopulmonary BypassCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K240908000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240908000Quantum Micro-Cardioplegia Delivery System; Quantum Micro-Cardioplegia Delivery Module (QMCDM)Spectrum Medical , Ltd.2025-07-08DTR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060434420831PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060434420831050604344208315060434420831

GMDN Terms#

Term, Definition table
TermDefinition
Bedside syringe pumpA mains electricity (AC-powered) non-ambulatory device designed to precisely drive the plunger of a syringe down its barrel to infuse a solution when it must be administered with a high degree of volume accuracy and rate consistency. Because of the lower flow settings and flow resolution (e.g., 0.1 ml/hr), it is especially appropriate for neonatal, infant, and critical care applications in which small volumes of concentrated drugs are to be delivered over an extended period. It can also be used to administer epidural analgesia. It will typically have internal batteries to allow operation for a short period of time when no line power is available (e.g., during transport or a power outage).

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
+441242650120eusales@spectrummedical.com
8002652331ussales@spectrummedical.com

Regulatory Flags#

DUNS number
516398679
Device count
1
HCT/P
true
Serial number
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
05060434420749Quantum ®QPF151-000024-002018-06-01
05060434420756Quantum ®QPF251-000025-002018-06-01
05060434420824QuantumQPF351-000056-002018-06-01
05060434420886QuantumQPR143-0009182018-05-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08054117372446TRILLYEUROSETS SRLDTR2026-05-05
08054117372545HORIZONEUROSETS SRLDTR2026-05-05
18051160302212Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 WSPECTRUM MEDICAL SRLDTR2026-03-18
18051160302236Quantum PureFlow Standard Heat Exchanger Low Flow 3/16 WSPECTRUM MEDICAL SRLDTR2025-12-23
18051160302274Quantum PureFlow Cardioplegia Heat Exchanger Low Flow 3/16 WSPECTRUM MEDICAL SRLDTR2025-12-23
08033178114288VanguardSORIN GROUP ITALIA SRLDTR2025-10-31
08033178114479VanguardSORIN GROUP ITALIA SRLDTR2025-10-31
08033178114486VanguardSORIN GROUP ITALIA SRLDTR2025-10-31
05060912587483CMO8 Adult PMP Oxygenator with Tubing PackCHALICE MEDICAL LIMITEDDTR2025-02-07
18051160302205Quantum PureFlow Standard Heat Exchanger High Flow 3/8 WSPECTRUM MEDICAL SRLDTR2024-11-19
18051160302267Quantum PureFlow Cardioplegia Heat Exchanger High Flow 1/4 WSPECTRUM MEDICAL SRLDTR2024-11-19
05060491619810CMO8 Adult PMP Oxygenator with Tubing PackCHALICE MEDICAL LIMITEDDTR2024-10-07
04987350743251CAPIOXTERUMO CORPORATIONDTR2024-05-20
54987350743256CAPIOXTERUMO CORPORATIONDTR2024-05-20
08033178112840KIDSSORIN GROUP ITALIA SRLDTR2024-03-20
08033178112864KIDSSORIN GROUP ITALIA SRLDTR2024-03-20
08033178113465KIDSSORIN GROUP ITALIA SRLDTR2024-03-20
08033178113472KIDSSORIN GROUP ITALIA SRLDTR2024-03-20
38033178113466KIDSSORIN GROUP ITALIA SRLDTR2024-03-20
05060491614129Adult Tubing Pack with Paragon Adult Maxi PMP OxygenatorCHALICE MEDICAL LIMITEDDTR2023-11-07
20634624530380MPS 3 Medical Air Hose KitQUEST MEDICAL INCDTR2023-10-16
05415067036414CentriMag™Thoratec CorporationDTR2023-05-17
18051160302168Quantum PureFlow Standard Heat Exchanger Low Flow 1/4 MSPECTRUM MEDICAL SRLDTR2023-05-04
18051160302175Quantum PureFlow Standard Heat Exchanger High Flow 3/8 MSPECTRUM MEDICAL SRLDTR2023-05-04
20634624530397MPS 3 Drug Pump CoverQUEST MEDICAL INCDTR2023-03-24
08051160301003Quantum PureFlow Standard Heat Exchanger Medium Flow 3/8SPECTRUM MEDICAL SRLDTR2022-05-30
08051160301171Quantum PureFlow Standard Heat Exchanger High Flow 3/8SPECTRUM MEDICAL SRLDTR2022-02-16
08051160301188Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4SPECTRUM MEDICAL SRLDTR2022-02-16
08051160301195Quantum PureFlow Standard Heat Exchanger Low Flow 3/16SPECTRUM MEDICAL SRLDTR2022-02-16
08051160301201Quantum PureFlow Standard Heat Exchanger Low Flow 1/4SPECTRUM MEDICAL SRLDTR2022-02-16