FDA.reportPublic FDA data

Quantum

Primary DI
05060434423832
Brand
Quantum
Company
SPECTRUM MEDICAL LIMITED
Model
52-000096-00
Catalog number
52-000096-00
Device description
IRMA Adaptor Kit
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
DTXGas Control Unit, Cardiopulmonary Bypass

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DTXGas Control Unit, Cardiopulmonary BypassCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K181942000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181942000Quantum Ventilation ModuleSpectrum Medical , Ltd.2018-10-18DTX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060434423832PrimaryGS10
15060434423839Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060434423832050604344238325060434423832
1506043442383915060434423839

GMDN Terms#

Term, Definition table
TermDefinition
Cardiopulmonary bypass system gas control unitA device that is a module of a cardiopulmonary bypass system and that is used to control and measure the flow of gas supplied into the oxygenator. It is calibrated for a specific gas and has a high degree of accuracy at low flows. It may be a flowmeter.

Storage And Handling#

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

Contacts#

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

Regulatory Flags#

DUNS number
516398679
Device count
10
Kit
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
05060434421890QuantumSPECTRUM MEDICAL LIMITEDDTX2024-07-26
05060434421906QuantumSPECTRUM MEDICAL LIMITEDDTX2024-02-27
05060434423818QuantumSPECTRUM MEDICAL LIMITEDDTX2022-10-25
15060434423815QuantumSPECTRUM MEDICAL LIMITEDDTX2022-10-25
15060434423839QuantumSPECTRUM MEDICAL LIMITEDDTX2022-10-25
05060434422699QuantumSPECTRUM MEDICAL LIMITEDDTX2021-09-16
05060434422842QuantumSPECTRUM MEDICAL LIMITEDDTX2021-09-16
05060434422859QuantumSPECTRUM MEDICAL LIMITEDDTX2021-09-16
05060434422347QuantumSPECTRUM MEDICAL LIMITEDDTX2021-05-06
05060434422514QuantumSPECTRUM MEDICAL LIMITEDDTX2021-05-06
05060434422798QuantumSPECTRUM MEDICAL LIMITEDDTX2021-05-06
05060434422064QuantumSPECTRUM MEDICAL LIMITEDDTX2020-12-10
05060434422071QuantumSPECTRUM MEDICAL LIMITEDDTX2020-12-10
05060434422736QuantumSPECTRUM MEDICAL LIMITEDDTX2020-12-10
05060434422743QuantumSPECTRUM MEDICAL LIMITEDDTX2020-12-10
05060434420879QuantumSPECTRUM MEDICAL LIMITEDDTX2019-04-03
05060434420688QuantumSPECTRUM MEDICAL LIMITEDDTX2019-01-14
04033817900702Electronic Gas BlenderLivaNova Deutschland GmbHDTX2015-10-20
04033817900696Electronic Gas BlenderLivaNova Deutschland GmbHDTX2015-10-16
04033817900719Electronic Gas BlenderLivaNova Deutschland GmbHDTX2015-10-14