FDA.reportPublic FDA data

Sarns™ Modular Perfusion System 8000

Primary DI
00886799000182
Brand
Sarns™ Modular Perfusion System 8000
Company
Terumo Cardiovascular Systems Corporation
Model
16402
Catalog number
16402
Device description
Roller Pump, 115V, System 8000
Published
2015-09-24
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
DWBPump, Blood, Cardiopulmonary Bypass, Roller Type

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWBPump, Blood, Cardiopulmonary Bypass, Roller TypeCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K915183000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K915183000SARNS 8000 MODULAR PERFUSION SYSTEM3M Health Care, Sarns1992-07-08DTQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00886799000182PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00886799000182008867990001828867990001820886799000182

GMDN Terms#

Term, Definition table
TermDefinition
Cardiopulmonary bypass system roller pumpA mains electricity (AC-powered) device that is a module of a cardiopulmonary bypass system and is used to circulate the blood flow outside of the body for gas exchange and reinfusion via a roller type mechanism. It may be designed with a single or a dual rotor head that presses the blood through the extracorporeal tubing set that is connected to the oxygenator and other parts of the heart-lung bypass system. This pump can also be used to deliver cardioplegia solution at a controlled volume to the patient.

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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00886799000212Sarns™ Modular Perfusion System 8000Terumo Cardiovascular Systems CorporationDWB2016-09-23
00886799000229Sarns™ Modular Perfusion System 8000Terumo Cardiovascular Systems CorporationDWB2016-09-23
00886799000236Sarns™ Modular Perfusion System 8000Terumo Cardiovascular Systems CorporationDWB2016-09-23
00886799000342Sarns™ Modular Perfusion System 8000Terumo Cardiovascular Systems CorporationDWB2016-09-23
00886799000595Terumo® Advanced Perfusion System 1Terumo Cardiovascular Systems CorporationDWB2016-09-23
00886799000649Terumo® Advanced Perfusion System 1Terumo Cardiovascular Systems CorporationDWB2016-09-23
00886799000687Terumo® Advanced Perfusion System 1Terumo Cardiovascular Systems CorporationDWB2016-09-23
00886799000724Terumo® Advanced Perfusion System 1Terumo Cardiovascular Systems CorporationDWB2016-09-23
00886799000731Terumo® Advanced Perfusion System 1Terumo Cardiovascular Systems CorporationDWB2016-09-23
00886799000748Terumo® Advanced Perfusion System 1Terumo Cardiovascular Systems CorporationDWB2016-09-23
00886799000755Terumo® Advanced Perfusion System 1Terumo Cardiovascular Systems CorporationDWB2016-09-23
00886799000762Terumo® Advanced Perfusion System 1Terumo Cardiovascular Systems CorporationDWB2016-09-23
00886799000779Terumo® Advanced Perfusion System 1Terumo Cardiovascular Systems CorporationDWB2016-09-23
00886799000830Terumo® Advanced Perfusion System 1Terumo Cardiovascular Systems CorporationDWB2016-09-23
00886799000847Terumo® Advanced Perfusion System 1Terumo Cardiovascular Systems CorporationDWB2016-09-23
00886799000878Terumo® Advanced Perfusion System 1Terumo Cardiovascular Systems CorporationDWB2016-09-23
00886799001721Sarns™ Modular Perfusion System 8000Terumo Cardiovascular Systems CorporationDWB2016-09-23