FDA.reportPublic FDA data

Quantum

Primary DI
15060434423815
Brand
Quantum
Company
SPECTRUM MEDICAL LIMITED
Model
52-000095-00
Catalog number
52-000095-00
Device description
Gas Sample Line 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
OTC
false
Sterile
false
Single use
false

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
K202733000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202733000Quantum Ventilation ModuleSpectrum Medical , Ltd.2020-10-16DTX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060434423818PrimaryGS10
15060434423815Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060434423818050604344238185060434423818
1506043442381515060434423815

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 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

Regulatory Flags#

DUNS number
516398679
Device count
10
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
05060434423832QuantumSPECTRUM 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