FDA.reportPublic FDA data

A.M.G. PMP Sterile

Primary DI
08034013782020
Brand
A.M.G. PMP Sterile
Company
EUROSETS SRL
Model
A.M.G. Module PMP NO T.P. Sterile
Catalog number
US5062
Published
2017-02-28
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08034013782037PackageGS11In Commercial Distribution
08034013782044PackageGS14In Commercial Distribution
08034013782020PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08034013782037080340137820378034013782037
08034013782044080340137820448034013782044
08034013782020080340137820208034013782020

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
439962374
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08052595517144HOLDERFLEXIBLE HOLDER SHORT US21942026-05-05
08052595517458HOLDER FIRM HOLDER LONG US24892026-05-05
08052595517465HOLDER FLEXIBLE HOLDER LONG US24902026-05-05
08054117372446TRILLYTrilly Oxygenator with Integrated Arterial Filter US52322026-05-05
08054117372545HORIZONHorizon AF Plus System (Integrated A.L. One AF PluUS53002026-05-05
08052705493351A.M.G.PMP PEDIATRIC A.M.G.PMP PEDIATRIC STERILEUS50872025-02-19
08052705493368AMG PMP INFANT STERILE AMG PMP INFANT STERILE US50882025-02-19
08034013785489HOLDERHolder for AMG PMP OXY MODULEUS22572025-02-19
18052705493358A.M.G.PMP PEDIATRIC A.M.G.PMP PEDIATRIC STERILEUS50872025-02-19
18052705493365AMG PMP INFANT STERILE AMG PMP INFANT STERILE US50882025-02-19
08052705496253A.M.G. PP SterileA.M.G. MODULE PP NO T.TP.STER.US54002020-05-11
18052705496250A.M.G. PP SterileA.M.G. MODULE PP NO T.TP.STER.US54002020-05-11
08034013782037A.M.G. PMP SterileA.M.G. Module PMP NO T.P. SterileUS50622017-02-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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
H965700393540NAMICNAVILYST MEDICAL, INC.DTZ2015-09-16
08033178100106AVANTSORIN GROUP ITALIA SRLDTZ2015-07-15