Home GUDID 04037691843353 QUADROX-i
Primary DI 04037691843353
Brand QUADROX-i
Company Maquet Cardiopulmonary AG
Model Small Adult
Catalog number 70105.5281
Published 2015-10-24
Public version status Update
Distribution status Not 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 DTR HEAT-EXCHANGER, CARDIOPULMONARY BYPASS
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class DTR Heat-Exchanger, Cardiopulmonary Bypass Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 04037691843353 Package GS1 4 Not in Commercial Distribution 04037691843346 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 04037691843353 04037691843353 4037691843353 04037691843346 04037691843346 4037691843346
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 316153865 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 true 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 04037691650326 ROTAFLOW Centrifugal Pump, SOFTLINE 70104.7553 2015-10-30 04037691645148 NA CARDIOHELP Emergency Drive holder, Rail 70104.9304 2016-02-29 04037691645155 NA CARDIOHELP Emergency Drive Holder, Mast 70104.8006 2016-02-29 04037691720791 NA CARDIOHELP Holder for mast HKH 9102-M 70104.9584 2016-02-29 04037691456584 NA Wall holder HKH 8820 70104.5366 2016-02-29 04037691717968 NA Cardiohelp Mobile Holder HKH 8860 70105.0897 2016-02-29 04037691718330 NA Gas bottle holder f. helicopter HKH 8880 70105.0901 2016-02-29 04058863084336 Cardiohelp Mobile Holder HKH 8860 70107.3079 2018-03-01 04037691075051 VBT Venous Bubble Trap BEQ-VBT 160, BIOLINE, Sterile 70103.0884 2017-03-13 04037691209722 NA VBT Venous Bubble Trap 70102.9805 2015-10-24 04037691349251 BMU 40 "BMU 40 Cell 1/2""" 70104.0804 2016-01-18 04037691349268 BMU 40 "BMU 40 Cell 3/8""" 70104.0844 2016-01-18 04037691349275 BMU 40 "BMU 40 Cell 1/4""" 70104.0845 2016-01-18 04037691349282 BMU 40 "BMU 40 Sensor 3/8""" 70104.0849 2016-01-18 04037691349299 BMU 40 "BMU 40 Sensor 1/4""" 70104.0850 2016-01-18 04037691349305 BMU 40 "BMU 40 Sensor 3/16""" 70104.0851 2016-01-18 04037691670164 QUADROX-i Pediatric, diffusion, BIOLINE 70105.0330 2015-10-24 04037691770970 QUADROX-i Pediatric, filter 70105.5215 2015-10-24 04058863017341 QUADROX-i HMO 71000-USA #SQUADROX-i Adult + Coating, Filter 70106.7823 2017-02-16 04058863017372 QUADROX-i BEQ-HMO 71000-USA #SQUADROX-i Adult+BIOLINE +Filte 70106.7829 2017-02-16
Other Devices Sharing Product Codes# 
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