FDA.reportPublic FDA data

APEX HP

Primary DI
08033178109901
Brand
APEX HP
Company
SORIN GROUP ITALIA SRL
Model
APEX HP M PHISIO
Published
2015-07-15
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
DTZOXYGENATOR, CARDIOPULMONARY BYPASS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DTZOxygenator, Cardiopulmonary BypassCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K083021000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K083021000APEX HP M PH.I.S.I.O. ADULT HOLLOW FIBER MEMBRANE OXYGENATORSorin Group Italia S.R.L.2008-10-29DTZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
38033178109902PackageGS12In Commercial Distribution
08033178109901PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3803317810990238033178109902
08033178109901080331781099018033178109901

GMDN Terms#

Term, Definition table
TermDefinition
Extracorporeal membrane oxygenatorA device designed for the extracorporeal diffusion of oxygen into blood across a gas-permeable membrane during a cardiopulmonary bypass or extracorporeal membrane oxygenation procedure. It includes a membrane that separates a thin layer of blood from the oxygenating gas; oxygen diffuses from the gas compartment into the blood, while carbon dioxide diffuses from the blood through the membrane and is flushed out of the oxygenator by the oxygen flow. The device may include an integrated heat exchanger, arterial filter, or cardiotomy/venous reservoir. 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
08033178102933DHF02 HEMOCONCENTRATOR2015-07-15
08033178102940DHF06 HEMOCONCENTRATOR2015-07-15
08033178109062CSC 14CSC14 + PURGE LINE2015-07-10
08033178112253INSPIRE6M2015-05-13
08033178112277INSPIRE6F M2015-05-13
08033178112284INSPIRE8F M2015-05-13
08033178112291INSPIREHVR2015-05-13
08033178112307INSPIREHVR DUAL2015-05-13
08033178112352INSPIRE6 PH.I.S.I.O.2015-05-13
08033178112369INSPIRE8 PH.I.S.I.O.2015-05-13
08033178112376INSPIRE6F PH.I.S.I.O.2015-05-13
08033178112383INSPIRE8F PH.I.S.I.O.2015-05-13
08033178112390INSPIRE6 DUAL PH.I.S.I.O.2015-05-13
08033178112406INSPIRE8 DUAL PH.I.S.I.O.2015-05-13
08033178112413INSPIRE6F DUAL PH.I.S.I.O.2015-05-13
08033178112420INSPIRE8F DUAL PH.I.S.I.O.2015-05-13
08033178113014INSPIRESVR 12002017-03-29
08033178113182INSPIRE7 M2019-08-28
08033178113212INSPIRE72019-08-28
08033178113236INSPIRE7 DUAL2019-08-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06974762681019LifemotionLifemotion Medical Technology Co., Ltd.DTZ2026-06-02
18051160300676Quantum Perfusion Blood Oxygenator VT200-E1SPECTRUM MEDICAL SRLDTZ2026-05-21
18051160300706Quantum Perfusion Blood Oxygenator with Integrated AF VT200-C2SPECTRUM MEDICAL SRLDTZ2026-05-21
18051160300768Quantum Perfusion Blood Oxygenator with Integrated AF VT160-C2SPECTRUM MEDICAL SRLDTZ2026-05-21
08054117372446TRILLYEUROSETS SRLDTZ2026-05-05
08054117372545HORIZONEUROSETS SRLDTZ2026-05-05
18051160302762Quantum Perfusion Blood Oxygenator VT200-E3SPECTRUM MEDICAL SRLDTZ2026-04-07
18051160302779Quantum Perfusion Blood Oxygenator VT160-E3SPECTRUM MEDICAL SRLDTZ2026-04-07
18051160303363Quantum Perfusion Blood Oxygenator VT75-E3SPECTRUM MEDICAL SRLDTZ2026-04-07
08052705493351A.M.G.PMP PEDIATRIC EUROSETS SRLDTZ2025-02-19
08052705493368AMG PMP INFANT STERILE EUROSETS SRLDTZ2025-02-19
08033178112840KIDSSORIN GROUP ITALIA SRLDTZ2024-03-20
08033178112864KIDSSORIN GROUP ITALIA SRLDTZ2024-03-20
08033178113465KIDSSORIN GROUP ITALIA SRLDTZ2024-03-20
08033178113472KIDSSORIN GROUP ITALIA SRLDTZ2024-03-20
08033178113342INSPIRESORIN GROUP ITALIA SRLDTZ2021-04-13
08033178113359INSPIRESORIN GROUP ITALIA SRLDTZ2021-04-13
08033178113366INSPIRESORIN GROUP ITALIA SRLDTZ2021-04-13
08052705496253A.M.G. PP SterileEUROSETS SRLDTZ2020-05-11
08033178113182INSPIRESORIN GROUP ITALIA SRLDTZ2019-08-28
08033178113212INSPIRESORIN GROUP ITALIA SRLDTZ2019-08-28
08033178113236INSPIRESORIN GROUP ITALIA SRLDTZ2019-08-28
08034013782020A.M.G. PMP SterileEUROSETS SRLDTZ2017-02-28
08033178250313RESERVOIRSORIN GROUP ITALIA SRLDTZ2016-09-15
00613994617309Affinity Pixie™MEDTRONIC, INC.DTZ2016-06-02
00643169178144Affinity Fusion®MEDTRONIC, INC.DTZ2016-05-02
00643169354869Affinity Fusion®MEDTRONIC, INC.DTZ2016-05-02
10887488435152CARDINAL HEALTHCardinal Health 200, LLCDTZ2016-01-27
08033178112758LILLIPUT PMPSORIN GROUP ITALIA SRLDTZ2015-11-25
00613994375636TRILLIUM® AFFINITY NT®MEDTRONIC, INC.DTZ2015-09-21