FDA.reportPublic FDA data

Quantum

Primary DI
05060434422484
Brand
Quantum
Company
SPECTRUM MEDICAL LIMITED
Model
52-000046-00
Catalog number
52-000046-00
Device description
Hose Kit - 9.5mm Bore 2.5m (kit of 2)
Published
2022-10-25
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
DWCController, Temperature, Cardiopulmonary Bypass

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWCController, Temperature, Cardiopulmonary BypassCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060434422484PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060434422484050604344224845060434422484

GMDN Terms#

Term, Definition table
TermDefinition
Cardiopulmonary bypass system heating/cooling unitA mains electricity (AC-powered) component of a cardiopulmonary bypass system designed to heat or cool a patient's body by extracorporeal heat exchange with the patient's perfused blood during a cardiopulmonary bypass procedure. It consists of a system to heat or cool a thermal transfer fluid, pumps to provide circulation of the fluid to a heat exchanger, and monitoring and alarm systems. It may be known as a hypothermia/hyperthermia unit because of its ability to regulate body temperature either way.

Storage And Handling#

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

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
00850054036254CardioQuip Dripless Hose Set 10' with 90 ConnectorsCARDIOQUIP, LLCDWC2025-10-27
00850054036261CardioQuip Dripless Hose Set 10' 90 Connectors and Straight HXCARDIOQUIP, LLCDWC2025-10-27
00850054036278CardioQuip Dripless Hose Set 10'CARDIOQUIP, LLCDWC2025-10-27
00850054036285CardioQuip Dripless Hose Set 10' with Straight HXCARDIOQUIP, LLCDWC2025-10-27
00850054036292CardioQuip Dripless Hose Set 10' with Blanket AdapterCARDIOQUIP, LLCDWC2025-10-27
00850054036308CardioQuip Dripless Hose Set 10' with Blanket Adapter and Straight HXCARDIOQUIP, LLCDWC2025-10-27
00850054036315CardioQuip Dripless End SetCARDIOQUIP, LLCDWC2025-10-27
00850054036322CardioQuip Dripless End Set with Straight HXCARDIOQUIP, LLCDWC2025-10-27
00850054036339"CardioQuip Oxygenator Connector, Right Angle, 1/2"" Hose Barb"CARDIOQUIP, LLCDWC2025-10-27
00850054036346"CardioQuip Oxygenator Connector. Straight, 1/2"" Hose Barb"CARDIOQUIP, LLCDWC2025-10-27
00850054036353"CardioQuip Main/CPG Connector. Male. Right Angle, 1/2"" Hose Barb"CARDIOQUIP, LLCDWC2025-10-27
00850054036360CardioQuip Standard Hose Set 10' with 90 ConnectorsCARDIOQUIP, LLCDWC2025-10-27
00850054036377CardioQuip Standard Hose Set 10' with 90 Connectors and Staight HXCARDIOQUIP, LLCDWC2025-10-27
00850054036384CardioQuip Standard Hose Set 10' with Blanket AdapterCARDIOQUIP, LLCDWC2025-10-27
00850054036391CardioQuip Standard Hose Set 10' with Blanket Adapter and Straight HXCARDIOQUIP, LLCDWC2025-10-27
00850054036407CardioQuip Standard Hose Set 10'CARDIOQUIP, LLCDWC2025-10-27
00850054036414CardioQuip Standard Hose Set 10' with Straight HXCARDIOQUIP, LLCDWC2025-10-27
00850054036421CardioQuip Dripless Hose Set 6'CARDIOQUIP, LLCDWC2025-10-27
00850054036438CardioQuip Dripless Hose Set 6' with Straight HXCARDIOQUIP, LLCDWC2025-10-27
00850054036445CardioQuip Standard Hose Set 6'CARDIOQUIP, LLCDWC2025-10-27
00850054036452CardioQuip Standard Hose Set 6' with Staight HXCARDIOQUIP, LLCDWC2025-10-27
00850054036605CardioQuip Mini wheel SetCARDIOQUIP, LLCDWC2025-10-27
05060434422460QuantumSPECTRUM MEDICAL LIMITEDDWC2022-10-25
05060434422477QuantumSPECTRUM MEDICAL LIMITEDDWC2022-10-25
05060434422491QuantumSPECTRUM MEDICAL LIMITEDDWC2022-10-25
05060434423757QuantumSPECTRUM MEDICAL LIMITEDDWC2022-06-09
05060434420961QuantumSPECTRUM MEDICAL LIMITEDDWC2022-05-18
00860000846103CardioQuip Modular Cooler-Heater (MCH)CARDIOQUIP, LLCDWC2020-12-08
00860000846110CardioQuip Modular Cooler-Heater (MCH)CARDIOQUIP, LLCDWC2020-12-08
00860000846127CardioQuip Refrigeration ModuleCARDIOQUIP, LLCDWC2020-12-08