FDA.reportPublic FDA data

Terumo® Advanced Perfusion System 1

Primary DI
00886799001806
Brand
Terumo® Advanced Perfusion System 1
Company
Terumo Cardiovascular Systems Corporation
Model
893479
Catalog number
893479
Device description
Lamp Assembly, LED, APS1
Published
2023-08-01
Public version status
New
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
K221895000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221895000Terumo Advanced Perfusion System 1Terumo Cardiovascular Systems Corporation2023-04-18DTQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00886799001806PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00886799001806008867990018068867990018060886799001806

GMDN Terms#

Term, Definition table
TermDefinition
Fixed examination/treatment room lightA fixed device intended to provide light to illuminate a site of patient examination and/or treatment. It typically consists of one or more light bulb(s) and, depending upon the design, reflectors or mirrors which focus and reflect the light. The device can be fixed to a ceiling, wall, or supported on a mobile mount. It can also be part of an operating light system consisting of more than one light head.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature0 Degrees Celsius40 Degrees Celsius
Storage Environment Temperature32 Degrees Fahrenheit104 Degrees Fahrenheit

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
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
00699753531406Cardiovascular Procedure Kit75472-012024-05-10
00699753531420Cardiovascular Procedure Kit75140-012024-05-10

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
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
04033817903079ESSENZLivaNova Deutschland GmbHDTQ2023-03-21