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
00699753537460Cardiovascular Procedure KitCX-DB080-012026-06-02
00699753537477Cardiovascular Procedure Kit787792026-06-02
00699753532731Cardiovascular Procedure Kit75959-022024-08-23
00699753532663Cardiovascular Procedure Kit73346-022024-08-20
00699753532250Cardiovascular Procedure Kit75197-012024-07-19
00699753531666Cardiovascular Procedure Kit74100-032024-06-04
00699753531345Cardiovascular Procedure Kit77087-012024-05-09
00699753531017Cardiovascular Procedure Kit65167-072024-03-21
00699753537439Cardiovascular Procedure KitCX-SV1272026-05-15
00699753537446Cardiovascular Procedure KitCX-SV1292026-05-15
00699753537453Cardiovascular Procedure Kit787752026-05-15
00812763011007OPUSWAVE01000-002026-05-13
00699753537378Cardiovascular Procedure KitCX-CZ2172026-05-05
00699753537361Cardiovascular Procedure KitCX-GE468X2026-05-04
00699753537385Cardiovascular Procedure KitCX-IS1272026-05-04
00699753537392Cardiovascular Procedure KitCX-SV1262026-05-04
00699753537408Cardiovascular Procedure KitCX-SV1282026-05-04
00699753537415Cardiovascular Procedure Kit780832026-05-04
00699753537422Cardiovascular Procedure Kit786492026-05-04
00699753532601Cardiovascular Procedure Kit74121-032024-08-08

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