FDA.reportPublic FDA data

Sarns™ Modular Perfusion System 8000

Primary DI
00886799000342
Brand
Sarns™ Modular Perfusion System 8000
Company
Terumo Cardiovascular Systems Corporation
Model
147361
Catalog number
147361
Device description
Flow meter
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
00886799000342PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00886799000342008867990003428867990003420886799000342

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
177655466
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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00699753531567Cardiovascular Procedure Kit72149-022024-05-29
00699753531574Cardiovascular Procedure Kit77742-012024-05-29
00699753517721Cardiovascular Procedure Kit75410-022022-10-19
00699753538177Cardiovascular Procedure Kit76754-012026-10-22
00699753538184Cardiovascular Procedure Kit788202026-10-22
00699753538191Cardiovascular Procedure KitCX-UK7722026-10-22
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

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