FDA.reportPublic FDA data

Terumo® Advanced Perfusion System 1

Primary DI
00886799001370
Brand
Terumo® Advanced Perfusion System 1
Company
Terumo Cardiovascular Systems Corporation
Model
816571
Catalog number
816571
Device description
The large roller pump is a peristaltic pump with a 6 inch (15 cm) raceway that can be used for arterial, cardioplegia, vent, and suction applications. A universl tube clamp mechanism accommodates a variety of tubing sizes, including dual tube sets.
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
DTQConsole, Heart-Lung Machine, Cardiopulmonary Bypass

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DTQConsole, Heart-Lung Machine, Cardiopulmonary BypassCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K151349000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151349000Advanced Perfusion System 1Terumo Cardiovascular Systems Corporation2015-08-27DTQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00886799001370PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00886799001370008867990013708867990013700886799001370

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
00699753537569Cardiovascular Procedure Kit787872026-07-08
00699753537576Cardiovascular Procedure Kit786052026-07-08
00699753537583Cardiovascular Procedure Kit787902026-07-08
00699753537590Cardiovascular Procedure Kit670602026-07-08
00699753537606Cardiovascular Procedure Kit787772026-07-08
00699753537613Cardiovascular Procedure KitCX-IS1292026-07-08
00699753537521Cardiovascular Procedure Kit76434-042026-06-24
00699753537538Cardiovascular Procedure Kit786942026-06-24
00699753532038Cardiovascular Procedure Kit76273-022024-07-09
00699753531956Cardiovascular Procedure Kit76873-032024-07-07
00699753512405Cardiovascular Procedure Kit75050-022020-04-23
00699753525054Cardiovascular Procedure KitCX-RU0642022-12-13
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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05060434424051Quantum SPECTRUM MEDICAL LIMITEDDTQ2024-02-27
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00886799002063Terumo® Advanced Perfusion System 1Terumo Cardiovascular Systems CorporationDTQ2023-11-03
00886799002070Terumo® Advanced Perfusion System 1Terumo Cardiovascular Systems CorporationDTQ2023-11-03
00886799002087Terumo® Advanced Perfusion System 1Terumo Cardiovascular Systems CorporationDTQ2023-11-03
00886799001806Terumo® Advanced Perfusion System 1Terumo Cardiovascular Systems CorporationDTQ2023-08-01
00886799001837Terumo® Advanced Perfusion System 1Terumo Cardiovascular Systems CorporationDTQ2023-06-20
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04033817902423AccessoriesLivaNova Deutschland GmbHDTQ2023-03-21
04033817902430AccessoriesLivaNova Deutschland GmbHDTQ2023-03-21
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04033817902454AccessoriesLivaNova Deutschland GmbHDTQ2023-03-21
04033817902461AccessoriesLivaNova Deutschland GmbHDTQ2023-03-21
04033817902478AccessoriesLivaNova Deutschland GmbHDTQ2023-03-21
04033817902485AccessoriesLivaNova Deutschland GmbHDTQ2023-03-21
04033817902492AccessoriesLivaNova Deutschland GmbHDTQ2023-03-21
04033817902997ESSENZLivaNova Deutschland GmbHDTQ2023-03-21
04033817903024ESSENZLivaNova Deutschland GmbHDTQ2023-03-21
04033817903031ESSENZLivaNova Deutschland GmbHDTQ2023-03-21
04033817903048ESSENZLivaNova Deutschland GmbHDTQ2023-03-21
04033817903055ESSENZLivaNova Deutschland GmbHDTQ2023-03-21
04033817903062ESSENZLivaNova Deutschland GmbHDTQ2023-03-21