FDA.reportPublic FDA data

Sarns™ Centrifugal System

Primary DI
00886799000076
Brand
Sarns™ Centrifugal System
Company
Terumo Cardiovascular Systems Corporation
Model
6379
Catalog number
6379
Device description
Centrifugal Pump Speed Control Module
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
DWAControl, Pump Speed, Cardiopulmonary Bypass

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWAControl, Pump Speed, Cardiopulmonary BypassCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K950739000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K9507390003M SARNS FLOW SENSOR, CENTRIFUGAL CONTROL MODULE 115, 220 V, 900 PERFUSION SYSTEM3M Health Care, Sarns1995-11-17DWA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00886799000076PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00886799000076008867990000768867990000760886799000076

GMDN Terms#

Term, Definition table
TermDefinition
Cardiopulmonary bypass system centrifugal pump drive unitA mains electricity (AC-powered) device that powers and controls the speed of a disposable cardiovascular bypass system centrifugal pump, to which it is connected, for the circulation of blood through the extracorporeal circuit for gas exchange and reinfusion. This device drives the centrifugal rotor of the disposable centrifugal pump using magnetism.

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
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
00699753537569Cardiovascular Procedure Kit787872026-07-08
00699753537576Cardiovascular Procedure Kit786052026-07-08
00699753537583Cardiovascular Procedure Kit787902026-07-08

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07290117830109INSPIRA ART100QTREX Quantum Ltd.DWA2024-11-10
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