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
00699753537743Cardiovascular Procedure Kit788052026-08-03
00699753537750Cardiovascular Procedure Kit788122026-08-03
00699753537767Cardiovascular Procedure Kit786712026-08-03
00699753530638Cardiovascular Procedure Kit75972-022024-02-22
00699753532625Cardiovascular Procedure Kit783422024-08-09
00699753532311Cardiovascular Procedure Kit74737-022024-07-22
00699753532083Cardiovascular Procedure Kit77746-012024-07-09
00699753531734Cardiovascular Procedure Kit76373-022024-06-12
00699753531673Cardiovascular Procedure Kit74101-012024-06-07
00699753530492Cardiovascular Procedure Kit74005-032024-02-15
00699753478145Cardiovascular Procedure Kit737182014-10-08
00699753537705Cardiovascular Procedure Kit73344-052026-07-22
00699753537712Cardiovascular Procedure Kit76212-012026-07-22
00699753537729Cardiovascular Procedure Kit787422026-07-22
00699753537736Cardiovascular Procedure Kit788032026-07-22
00699753537651Cardiovascular Procedure KitCX-CZ219X2026-07-20
00699753537668Cardiovascular Procedure KitCX-CZ220X2026-07-20
00699753537675Cardiovascular Procedure KitCX-CZ221X2026-07-20
00699753537682Cardiovascular Procedure KitCX-CZ222X2026-07-20
00699753537699Cardiovascular Procedure Kit788022026-07-20

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