Home GUDID 08054117378264 HORIZON 8AF
Primary DI 08054117378264
Brand HORIZON 8AF
Company EUROSETS SRL
Model HORIZON 8AF (Integrated OXY MODULE 8AF and Horizon
Catalog number US5305
Published 2026-10-15
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile true
Single use true Product Codes# Code, Name table Code Name DTM Filter, Blood, Cardiopulmonary Bypass, Arterial Line DTN Reservoir, Blood, Cardiopulmonary Bypass DTR Heat-Exchanger, Cardiopulmonary Bypass DTZ Oxygenator, Cardiopulmonary Bypass
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DTM Filter, Blood, Cardiopulmonary Bypass, Arterial Line Cardiovascular 2 DTN Reservoir, Blood, Cardiopulmonary Bypass Cardiovascular 2 DTR Heat-Exchanger, Cardiopulmonary Bypass Cardiovascular 2 DTZ Oxygenator, Cardiopulmonary Bypass Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 02805411737822 Package GS1 1 In Commercial Distribution 18054117378261 Package GS1 1 In Commercial Distribution 08054117378264 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 02805411737822 02805411737822 2805411737822 18054117378261 18054117378261 08054117378264 08054117378264 8054117378264
GMDN Terms# Term, Definition table Term Definition Extracorporeal membrane oxygenator A 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 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 08052595517144 HOLDER FLEXIBLE HOLDER SHORT US2194 2026-05-05 08052595517458 HOLDER FIRM HOLDER LONG US2489 2026-05-05 08052595517465 HOLDER FLEXIBLE HOLDER LONG US2490 2026-05-05 08054117372446 TRILLY Trilly Oxygenator with Integrated Arterial Filter US5232 2026-05-05 08054117372545 HORIZON Horizon AF Plus System (Integrated A.L. One AF Plu US5300 2026-05-05 08052705493351 A.M.G.PMP PEDIATRIC A.M.G.PMP PEDIATRIC STERILE US5087 2025-02-19 08052705493368 AMG PMP INFANT STERILE AMG PMP INFANT STERILE US5088 2025-02-19 08034013785489 HOLDER Holder for AMG PMP OXY MODULE US2257 2025-02-19 18052705493358 A.M.G.PMP PEDIATRIC A.M.G.PMP PEDIATRIC STERILE US5087 2025-02-19 18052705493365 AMG PMP INFANT STERILE AMG PMP INFANT STERILE US5088 2025-02-19 08052705496253 A.M.G. PP Sterile A.M.G. MODULE PP NO T.TP.STER. US5400 2020-05-11 08034013782020 A.M.G. PMP Sterile A.M.G. Module PMP NO T.P. Sterile US5062 2017-02-28 18052705496250 A.M.G. PP Sterile A.M.G. MODULE PP NO T.TP.STER. US5400 2020-05-11 08034013782037 A.M.G. PMP Sterile A.M.G. Module PMP NO T.P. Sterile US5062 2017-02-28
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