FDA.reportPublic FDA data

Sarns™ Modular Perfusion System 8000

Primary DI
00886799000212
Brand
Sarns™ Modular Perfusion System 8000
Company
Terumo Cardiovascular Systems Corporation
Model
16414
Catalog number
16414
Device description
Cardioplegia Monitor
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
DSJAlarm, Blood-Pressure
DSKComputer, Blood-Pressure
DTQConsole, Heart-Lung Machine, Cardiopulmonary Bypass
DTWMonitor And/Or Control, Level Sensing, Cardiopulmonary Bypass
DWAControl, Pump Speed, Cardiopulmonary Bypass
DWBPump, Blood, Cardiopulmonary Bypass, Roller Type
DWCController, Temperature, Cardiopulmonary Bypass
KRIAccessory Equipment, Cardiopulmonary Bypass
KRLDetector, Bubble, Cardiopulmonary Bypass

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DSJAlarm, Blood-PressureCardiovascular2
DSKComputer, Blood-PressureCardiovascular2
DTQConsole, Heart-Lung Machine, Cardiopulmonary BypassCardiovascular2
DTWMonitor And/Or Control, Level Sensing, Cardiopulmonary BypassCardiovascular2
DWAControl, Pump Speed, Cardiopulmonary BypassCardiovascular2
DWBPump, Blood, Cardiopulmonary Bypass, Roller TypeCardiovascular2
DWCController, Temperature, Cardiopulmonary BypassCardiovascular2
KRIAccessory Equipment, Cardiopulmonary BypassCardiovascular1
KRLDetector, Bubble, Cardiopulmonary BypassCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K960916000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K960916000SAMS 8000 CARDIOPLEGIA MONITOR3M Health Care, Sarns1996-06-04DSJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00886799000212PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00886799000212008867990002128867990002120886799000212

GMDN Terms#

Term, Definition table
TermDefinition
Cardiopulmonary bypass system mounting unitA platform upon which modular devices of a cardiopulmonary bypass system (e.g., the blood pumps) are mounted to form the complete system. It typically includes electronics and control panels (e.g., microprocessors to control pump speed), and the main connection to the source of line power. It serves as the basic workstation for the operator to monitor and control the system's functions.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
177655466
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00699753538061Cardiovascular Procedure KitCX-CZ227X2026-10-09
00699753538078Cardiovascular Procedure KitCX-CZ2282026-10-09
00699753538085Cardiovascular Procedure KitCX-SP296X2026-10-09
00699753538092Cardiovascular Procedure KitCX-SP297X2026-10-09
00699753538108Cardiovascular Procedure Kit787582026-10-09
00699753538115Cardiovascular Procedure Kit788232026-10-09
00699753538122Cardiovascular Procedure Kit787472026-10-09
00699753538139Cardiovascular Procedure Kit787482026-10-09
00699753538146Cardiovascular Procedure Kit787442026-10-09
00699753538153Cardiovascular Procedure Kit787462026-10-09
00699753538160Cardiovascular Procedure Kit787452026-10-09
00699753538054Cardiovascular Procedure Kit786082026-09-24
00699753537880Cardiovascular Procedure Kit788312026-08-26
00699753537897Cardiovascular Procedure Kit788332026-08-26
00699753537903Cardiovascular Procedure KitCX-CZ226X2026-08-26
00699753537910Cardiovascular Procedure KitCX-UK7672026-08-26
00699753537927Cardiovascular Procedure KitCX-UK7682026-08-26
00699753537934Cardiovascular Procedure KitCX-UK7692026-08-26
00699753537941Cardiovascular Procedure KitCX-UK770X2026-08-26
00699753537958Cardiovascular Procedure KitCX-UK7712026-08-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10884450356408Safedraw™ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.DSK2026-10-07
10884450372965Safedraw™ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.DSK2026-10-07
00195278949752TruSignal SpO2 MM 3.0MGE Healthcare Finland OyDSJ2026-10-04
00195278949752TruSignal SpO2 MM 3.0MGE Healthcare Finland OyDSK2026-10-04
00195278949769TruSignal SpO2 MM 1.8MGE Healthcare Finland OyDSK2026-10-04
00195278949769TruSignal SpO2 MM 1.8MGE Healthcare Finland OyDSJ2026-10-04
00198953002186Carescape Dock F0GE Healthcare Finland OyDSK2026-10-04
00198953002186Carescape Dock F0GE Healthcare Finland OyDSJ2026-10-04
00198953009567Carescape ONEGE Healthcare Finland OyDSK2026-10-04
00198953009567Carescape ONEGE Healthcare Finland OyDSJ2026-10-04
00634624530485MPS® 3 Console Pole Mount PlateQUEST MEDICAL INCDWC2026-07-20
34033817902394Level ControlLivaNova Deutschland GmbHDTQ2026-07-20
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
07640135140153CentriMag™Thoratec CorporationDWA2026-02-19
00191506052454MDU5 Plus™BOSTON SCIENTIFIC CORPORATIONDSK2025-12-09
00883873760420ASSY,CABLE,ADAPTER,TEMPERATURE,M-PAK,LP35,10FTPHYSIO-CONTROL, INC.DSK2025-09-26
00883873760437ASSY, CABLE, ADAPTER, TEMP, LP35, 6FT,IRONGANPHYSIO-CONTROL, INC.DSK2025-09-26
00883873760444ASSY, CABLE, ADAPTER, IP, ICU, LP35PHYSIO-CONTROL, INC.DSK2025-09-26
00883873760451ASSY, CABLE, ADAPTER, IP, EDWARDS, LP35PHYSIO-CONTROL, INC.DSK2025-09-26
B510PMMAX13ADVANCED PATIENT MONITORADVANCED INSTRUMENTATIONS, INC.DSK2024-12-19
B510PMMAX15ADVANCED PATIENT MONITORADVANCED INSTRUMENTATIONS, INC.DSK2024-12-19
07290117830055INSPIRA ART100QTREX Quantum Ltd.DWA2024-11-10
07290117830062INSPIRA ART100QTREX Quantum Ltd.DWA2024-11-10