FDA.reportPublic FDA data

Terumo® Advanced Perfusion System 1

Primary DI
00886799000762
Brand
Terumo® Advanced Perfusion System 1
Company
Terumo Cardiovascular Systems Corporation
Model
803479
Catalog number
803479
Device description
The Interface Module for CDI 500 Module provides the interface between the CDI™ 500 Blood Parameter Monitoring System and the APS1. The module communicates the CDI 500 monitor values to the system for display on the CCM.
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
DTQConsole, Heart-Lung Machine, Cardiopulmonary Bypass
DWBPump, Blood, Cardiopulmonary Bypass, Roller Type

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DTQConsole, Heart-Lung Machine, Cardiopulmonary BypassCardiovascular2
DWBPump, Blood, Cardiopulmonary Bypass, Roller TypeCardiovascular2

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
00886799000762PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00886799000762008867990007628867990007620886799000762

GMDN Terms#

Term, Definition table
TermDefinition
Cardiopulmonary bypass system, roller typeAn assembly of devices that provides mechanical circulatory support during open-heart surgery, bypassing the heart to facilitate surgery on the organ. The basic function of the machine is to oxygenate the body's venous supply of blood and then pump it back into the arterial circuit. It will typically provide intracardiac suction, filtration, and temperature control. This device typically consists of mains electricity (AC-powered) console with roller pumps, oxygenators, a heat exchanger, temperature regulators, a reservoir, filters, a defoamer, and a handcrank for manual emergency rotation of a blood pump. Some systems are manufactured as a single unit while others are made up of modules.

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
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04033817904144DeviceLivaNova Deutschland GmbHDTQ2026-01-22
04033817901693Virtual Kit NumberLivaNova Deutschland GmbHDTQ2024-07-23
05060434424044QuantumSPECTRUM MEDICAL LIMITEDDTQ2024-02-27
05060434424051Quantum SPECTRUM MEDICAL LIMITEDDTQ2024-02-27
04033817903017ESSENZLivaNova Deutschland GmbHDTQ2024-02-22
00886799002056Terumo® Advanced Perfusion System 1Terumo Cardiovascular Systems CorporationDTQ2023-11-03
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
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00886799001837Terumo® Advanced Perfusion System 1Terumo Cardiovascular Systems CorporationDTQ2023-06-20
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00886799001813Terumo® Advanced Perfusion System 1Terumo Cardiovascular Systems CorporationDTQ2023-05-18
05415067036414CentriMag™Thoratec CorporationDTQ2023-05-17
04033817902423AccessoriesLivaNova Deutschland GmbHDTQ2023-03-21
04033817902430AccessoriesLivaNova Deutschland GmbHDTQ2023-03-21
04033817902447AccessoriesLivaNova Deutschland GmbHDTQ2023-03-21
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