FDA.reportPublic FDA data

Quantum

Primary DI
05060434421890
Brand
Quantum
Company
SPECTRUM MEDICAL LIMITED
Model
QLS1-200
Catalog number
51-000069-00
Device description
Quantum Reservoir Level Sensor - Single Head 2.0m
Published
2024-07-26
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
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
05060434421890PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060434421890050604344218905060434421890

GMDN Terms#

Term, Definition table
TermDefinition
Cardiopulmonary bypass system air bubble/fluid level detectorA mains electricity (AC-powered) device designed to detect air bubbles in blood returned to the body from the extracorporeal circuit of a cardiopulmonary (heart-lung) bypass system, and to detect when blood falls below acceptable levels, typically in the venous drip chamber. The device typically consists of an electronic unit and ultrasonic sensors; it usually triggers alarms and activates automated mechanisms to turn off the blood flow when bubbles are detected or an abnormal fluid level occurs. It is typically an integral part of the cardiopulmonary bypass system.

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
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
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
05060434421906QuantumSPECTRUM MEDICAL LIMITEDDTX2024-02-27
05060434423818QuantumSPECTRUM MEDICAL LIMITEDDTX2022-10-25
05060434423832QuantumSPECTRUM 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