FDA.reportPublic FDA data

DATA MASTER

Primary DI
08033178104708
Brand
DATA MASTER
Company
SORIN GROUP ITALIA SRL
Model
V12 SAT - 1/2 x 1/2
Published
2016-03-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
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
K092463000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K092463000SORIN B-CARE5 FOR THE STOCKERT S5 SYSTEMSorin Group Deutschland GmbH2009-11-05DTQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
38033178104709PackageGS150In Commercial Distribution
08033178104708PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3803317810470938033178104709
08033178104708080331781047088033178104708

GMDN Terms#

Term, Definition table
TermDefinition
Cardiopulmonary bypass system blood gas sensorA sterile transducer used with a cardiopulmonary bypass system to detect and measure the partial pressure of gases in the blood being circulated by the system. This is a single-use device.

Regulatory Flags#

DUNS number
442126587
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08033178018203Venous Cardiopolmunary Bypass CannulaRDS-610342025-12-19
08033178018227Venous Cardiopolmunary Bypass CannulaRDS-610402025-12-19
08033178018234Venous Cardiopolmunary Bypass CannulaRDS-610462025-12-19
08033178018258Venous Cardiopolmunary Bypass CannulaRDS-611342025-12-19
08033178018272Venous Cardiopolmunary Bypass CannulaRDS-611402025-12-19
08033178018289Venous Cardiopolmunary Bypass CannulaRDS-611462025-12-19
08033178018296Venous Cardiopolmunary Bypass CannulaRDS-611502025-12-19
08033178018364Venous Cardiopolmunary Bypass CannulaRV-400162025-12-19
08033178018371Venous Cardiopolmunary Bypass CannulaRV-400182025-12-19
08033178018388Venous Cardiopolmunary Bypass CannulaRV-400202025-12-19
08033178018395Venous Cardiopolmunary Bypass CannulaRV-400222025-12-19
08033178018401Venous Cardiopolmunary Bypass CannulaRV-400242025-12-19
08033178018418Venous Cardiopolmunary Bypass CannulaRV-400262025-12-19
08033178018425Venous Cardiopolmunary Bypass CannulaRV-400282025-12-19
08033178018432Venous Cardiopolmunary Bypass CannulaRV-400302025-12-19
08033178018449Venous Cardiopolmunary Bypass CannulaRV-400322025-12-19
08033178018456Venous Cardiopolmunary Bypass CannulaRV-400342025-12-19
08033178018463Venous Cardiopolmunary Bypass CannulaRV-400362025-12-19
08033178018487Venous Cardiopolmunary Bypass CannulaRV-405362025-12-19
08033178018524Venous Cardiopolmunary Bypass CannulaRV-410182025-12-19

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