TRILLY

Primary DI
08054117372446
Brand
TRILLY
Company
EUROSETS SRL
Model
Trilly Oxygenator with Integrated Arterial Filter
Catalog number
US5232
Published
2026-05-05
Public version status
New
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
DTMFilter, Blood, Cardiopulmonary Bypass, Arterial Line
DTNReservoir, Blood, Cardiopulmonary Bypass
DTRHeat-Exchanger, Cardiopulmonary Bypass
DTZOxygenator, Cardiopulmonary Bypass

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DTMFilter, Blood, Cardiopulmonary Bypass, Arterial LineCardiovascular2
DTNReservoir, Blood, Cardiopulmonary BypassCardiovascular2
DTRHeat-Exchanger, Cardiopulmonary BypassCardiovascular2
DTZOxygenator, Cardiopulmonary BypassCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K242503000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K242503000Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232)Eurosets S.R.L2025-11-24DTZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18054117372443PackageGS11In Commercial Distribution
28054117372440PackageGS12In Commercial Distribution
08054117372446PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1805411737244318054117372443
2805411737244028054117372440
08054117372446080541173724468054117372446

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
Manufacturing date on label
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
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
08034013782020A.M.G. PMP SterileA.M.G. Module PMP NO T.P. SterileUS50622017-02-28
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
08054117372545HORIZONEUROSETS SRLDTN2026-05-05
08054117372545HORIZONEUROSETS SRLDTM2026-05-05
08054117372545HORIZONEUROSETS SRLDTR2026-05-05
08054117372545HORIZONEUROSETS SRLDTZ2026-05-05
B00962623OCS HEART LEUKOCYTE DEPLETING FILTERTRANSMEDICS, INC.DTM2026-05-04
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
18051160302212Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 WSPECTRUM MEDICAL SRLDTR2026-03-18
08033178113144INSPIRESORIN GROUP ITALIA SRLDTN2026-01-16
08033178113151INSPIRESORIN GROUP ITALIA SRLDTN2026-01-16
08033178112857KidsSORIN GROUP ITALIA SRLDTM2025-10-31
08033178112871KidsSORIN GROUP ITALIA SRLDTM2025-10-31
08033178114288VanguardSORIN GROUP ITALIA SRLDTR2025-10-31
08033178114479VanguardSORIN GROUP ITALIA SRLDTR2025-10-31
08033178114486VanguardSORIN GROUP ITALIA SRLDTR2025-10-31
08033178114561MICROSORIN GROUP ITALIA SRLDTM2025-03-04
08033178114578MICROSORIN GROUP ITALIA SRLDTM2025-03-04
08033178114608MICROSORIN GROUP ITALIA SRLDTM2025-03-04
08052705493351A.M.G.PMP PEDIATRIC EUROSETS SRLDTZ2025-02-19
08052705493368AMG PMP INFANT STERILE EUROSETS SRLDTZ2025-02-19
08033178113717XTRASORIN GROUP ITALIA SRLDTN2024-12-20
08033178113731XTRASORIN GROUP ITALIA SRLDTN2024-12-20
08033178113748XTRASORIN GROUP ITALIA SRLDTN2024-12-20
08033178113755XTRASORIN GROUP ITALIA SRLDTN2024-12-20
08033178113762XTRASORIN GROUP ITALIA SRLDTN2024-12-20
08033178113922XTRASORIN GROUP ITALIA SRLDTN2024-12-20