FDA.reportPublic FDA data

Terumo® Advanced Perfusion System 1

Primary DI
00886799000595
Brand
Terumo® Advanced Perfusion System 1
Company
Terumo Cardiovascular Systems Corporation
Model
801238
Catalog number
801238
Device description
"The 33"" gooseneck, 20 watt lamp is intended to be mounted on any of the system poles"
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
00886799000595PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00886799000595008867990005958867990005950886799000595

GMDN Terms#

Term, Definition table
TermDefinition
Desk mountA non-dedicated (general-purpose) manually-operated structure designed to be fixed to a desk or a worktop and onto which another medical device (not included) is intended to be safely affixed or mounted. This device is typically clamped (i.e., removable) or permanently screwed to the desk or a worktop surface.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
177655466
Device count
1
Lot or batch
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
04033817904137DeviceLivaNova Deutschland GmbHDTQ2026-01-22
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
00886799001806Terumo® Advanced Perfusion System 1Terumo Cardiovascular Systems CorporationDTQ2023-08-01
00886799001837Terumo® Advanced Perfusion System 1Terumo Cardiovascular Systems CorporationDTQ2023-06-20
00886799001844Terumo® Advanced Perfusion System 1Terumo Cardiovascular Systems CorporationDTQ2023-06-20
00886799001820Terumo® Advanced Perfusion System 1Terumo Cardiovascular Systems CorporationDTQ2023-05-24
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