FDA.reportPublic FDA data

Quantum

Primary DI
25060434423973
Brand
Quantum
Company
SPECTRUM MEDICAL LIMITED
Model
LSC_HRC70
Catalog number
LSC_HRC70
Device description
Quantum Reservoir Level Sensor Cradle - R70.5
Published
2023-12-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KRIAccessory Equipment, Cardiopulmonary Bypass

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KRIAccessory Equipment, Cardiopulmonary BypassCardiovascular1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060434423979PrimaryGS10
25060434423973Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060434423979050604344239795060434423979
2506043442397325060434423973

GMDN Terms#

Term, Definition table
TermDefinition
Sensor holder, single-useA device designed to hold (house) a sensor so that it is fixed (locked) in a stable position, including adhesive fixation. It will then allow for the holder and the attached sensor to be fastened to, e.g., the patient's body, another device, or a suitable place in the vicinity of use. This is a single-use device.

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

Regulatory Flags#

DUNS number
516398679
Device count
100
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
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
06974762682221LifemotionLifemotion Medical Technology Co., Ltd.KRI2026-06-05
06974762681101LifemotionLifemotion Medical Technology Co., Ltd.KRI2026-06-02
18051160302137Quantum Perfusion Capnometer Line SetSPECTRUM MEDICAL SRLKRI2026-05-21
28051160301564Quantum PureFlow KIT CPC - Barbed Connector AdaptorSPECTRUM MEDICAL SRLKRI2026-05-21
28051160301571Quantum PureFlow KIT CPC - Hansen Connector AdaptorSPECTRUM MEDICAL SRLKRI2026-05-21
08052595517144HOLDEREUROSETS SRLKRI2026-05-05
08052595517458HOLDEREUROSETS SRLKRI2026-05-05
08052595517465HOLDEREUROSETS SRLKRI2026-05-05
05060434424457QuantumSPECTRUM MEDICAL LIMITEDKRI2026-03-20
05060434424532QuantumSPECTRUM MEDICAL LIMITEDKRI2026-03-09
05415067034441CentriMag™Thoratec CorporationKRI2026-02-02
00850054036629Cardio Quip VivaCart Short Infusion Pole with Removable HooksCARDIOQUIP, LLCKRI2025-10-28
08034013785489HOLDEREUROSETS SRLKRI2025-02-19
07290117830079INSPIRA CARTINSPIRA TECHNOLOGIES OXY B.H.N LTDKRI2024-11-10
17290117830076INSPIRA CARTINSPIRA TECHNOLOGIES OXY B.H.N LTDKRI2024-11-10
10850007732353VitalFlow CaddyMICHIGAN CRITICAL CARE CONSULTANTS, INC.KRI2024-09-19
05060434423962QuantumSPECTRUM MEDICAL LIMITEDKRI2023-12-22
05060434423979QuantumSPECTRUM MEDICAL LIMITEDKRI2023-12-22
05060434423986Quantum SPECTRUM MEDICAL LIMITEDKRI2023-12-22
25060434423966QuantumSPECTRUM MEDICAL LIMITEDKRI2023-12-22
25060434423980Quantum SPECTRUM MEDICAL LIMITEDKRI2023-12-22
08033178101547Sinergy and Mini Bag CPBSORIN GROUP ITALIA SRLKRI2023-10-24
08033178101622Vanguard, CSC 14 and HSCSORIN GROUP ITALIA SRLKRI2023-10-24
08033178102292DAC CardiotomySORIN GROUP ITALIA SRLKRI2023-10-24
08033178102384ExchangerSORIN GROUP ITALIA SRLKRI2023-10-24
08033178103428HemoconcentratorSORIN GROUP ITALIA SRLKRI2023-10-24
08033178109857D100/D101SORIN GROUP ITALIA SRLKRI2023-10-24
08033178109864D130/D131 KIDS Arterial FilterSORIN GROUP ITALIA SRLKRI2023-10-24
08033178111959InspireSORIN GROUP ITALIA SRLKRI2023-10-24
08033178111966InspireSORIN GROUP ITALIA SRLKRI2023-10-24