FDA.reportPublic FDA data

Cardiopulmonary bypass system, roller type

Definition
An assembly of devices that provides mechanical circulatory support during open-heart surgery, bypassing the heart to facilitate surgery on the organ. The basic function of the machine is to oxygenate the body's venous supply of blood and then pump it back into the arterial circuit. It will typically provide intracardiac suction, filtration, and temperature control. This device typically consists of mains electricity (AC-powered) console with roller pumps, oxygenators, a heat exchanger, temperature regulators, a reservoir, filters, a defoamer, and a handcrank for manual emergency rotation of a blood pump. Some systems are manufactured as a single unit while others are made up of modules.
GUDID devices
266
Last updated
2026-07-30 21:30:47

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
34033817902394Level ControlLivaNova Deutschland GmbHPads2026-07-20
04037691258997ROTAFLOWMaquet Cardiopulmonary AGDrive2015-11-12
04037691259000ROTAFLOWMaquet Cardiopulmonary AGEmergency Drive2015-11-12
04037691562445ROTAFLOWMaquet Cardiopulmonary AGConsole, English/ US2015-11-12
04037691658247MAQUET CARDIOHELPMaquet Cardiopulmonary AGCARDIOHELP Base Unit2015-11-06
04037691658384MAQUET CARDIOHELPMaquet Cardiopulmonary AGCARDIOHELP System2015-11-06
04037691679013ROTAFLOWMaquet Cardiopulmonary AGICU Console, English/ US2015-11-12
10809160047392AVID TruCustomAVID MEDICAL, INC.SAMM047-09_00052016-09-09
10809160050811AVID TruCustomAVID MEDICAL, INC.OSUM186-10_00042016-09-10
10809160209004AVID TruCustomAVID MEDICAL, INC.LANK015-03_00212018-09-12
10809160209165AVID TruCustomAVID MEDICAL, INC.GLPP004-01_00082018-09-13
10809160209431AVID TruCustomAVID MEDICAL, INC.UNVM135-05_00032018-09-14
10809160209448AVID TruCustomAVID MEDICAL, INC.MMOR9233_00042018-09-14
10809160209493AVID TruCustomAVID MEDICAL, INC.SCRA001_00112018-09-14
10809160209714AVID TruCustomAVID MEDICAL, INC.MOSE8449_00052018-09-17
10809160209721AVID TruCustomAVID MEDICAL, INC.MOSE9427_00062018-09-17
10809160209738AVID TruCustomAVID MEDICAL, INC.OLLM002_00042018-09-17
10809160209745AVID TruCustomAVID MEDICAL, INC.OLLM9448_00032018-09-17
10809160209752AVID TruCustomAVID MEDICAL, INC.OKHH001_00032018-09-17
10809160209776AVID TruCustomAVID MEDICAL, INC.OKHH002_00032018-09-18
10809160209783AVID TruCustomAVID MEDICAL, INC.OKHH005_00032018-09-18
10809160209790AVID TruCustomAVID MEDICAL, INC.OKHH004_00042018-09-18
10809160209820AVID TruCustomAVID MEDICAL, INC.FGHM100_00042018-09-18
10809160209998AVID TruCustomAVID MEDICAL, INC.ADVG031-33_00062018-09-20
10809160210192AVID TruCustomAVID MEDICAL, INC.LAKC038-03AUX_00012018-09-21
04033817904137DeviceLivaNova Deutschland GmbHHOLDER WITH MAST-CLAMP LONG2026-01-22
04033817904144DeviceLivaNova Deutschland GmbHCOCKPITARM - VARIABLE HEIGHT2026-01-22
04037691643526MAQUET CARDIOHELPMaquet Cardiopulmonary AGCARDIOHELP Emergency Drive (w/o holder)2015-11-10
04033817901693Virtual Kit NumberLivaNova Deutschland GmbHS5 LUFTBLASENÜBWERWACHUNG APC2024-07-23
04033817900023Venous Line ClampLivaNova Deutschland GmbH"Plastic Inserts 1/4"" x 1/16"""2015-10-14
04033817900030Venous Line ClampLivaNova Deutschland GmbH"Plastic Inserts 1/4"" x 3/32"""2015-10-14
04033817900047Venous Line ClampLivaNova Deutschland GmbH"Plastic Inserts 3/8"" x 1/16"""2015-10-20
04033817900054Venous Line ClampLivaNova Deutschland GmbH"Plastic Inserts 3/8"" x 3/32"""2015-10-16
04033817900061Venous Line ClampLivaNova Deutschland GmbH"Plastic Inserts 1/2"" x 1/16"""2015-10-14
04033817900078Venous Line ClampLivaNova Deutschland GmbH"Plastic Inserts 1/2"" x 3/32"""2015-10-14
04033817900085Venous Line ClampLivaNova Deutschland GmbH"Plastic Inserts 5/8"" x 3/32"""2015-10-20
04033817900092Venous Line ClampLivaNova Deutschland GmbH"Plastic Inserts 1/8"" x 1/16"""2015-10-14
04033817900108Venous Line ClampLivaNova Deutschland GmbH"Plastic Inserts 3/16"" x 1/16"""2015-10-16
04033817900115Venous Line ClampLivaNova Deutschland GmbH"Metal Inserts 1/4"" x 1/16"""2015-10-14
04033817900122Venous Line ClampLivaNova Deutschland GmbH"Metal Inserts 1/4"" x 3/32"""2015-10-14
04033817900139Venous Line ClampLivaNova Deutschland GmbH"Metal Inserts 3/8"" x 1/16"""2015-10-20
04033817900146Venous Line ClampLivaNova Deutschland GmbH"Metal Inserts 3/8"" x 3/32"""2015-10-16
04033817900153Venous Line ClampLivaNova Deutschland GmbH"Metal Inserts 1/2"" x 1/16"""2015-10-14
04033817900160Venous Line ClampLivaNova Deutschland GmbH"Metal Inserts 1/2"" x 3/32"""2015-10-16
04033817900177Venous Line ClampLivaNova Deutschland GmbH"Metal Inserts 5/8"" x 3/32"""2015-10-20
04033817900184VariolockLivaNova Deutschland GmbHInserts Large2015-10-14
04033817900191VariolockLivaNova Deutschland GmbHInserts Small2015-10-14
04033817900207VariolockLivaNova Deutschland GmbHInserts Cardioplegia 1:12015-10-20
04033817900214VariolockLivaNova Deutschland GmbHInserts Cardioplegia 2:12015-10-14
04033817900221VariolockLivaNova Deutschland GmbHInserts Cardioplegia 4:12015-10-14
04033817900238VariolockLivaNova Deutschland GmbHInserts Cardioplegia 4:12015-10-16
04033817900245S5 Roller Pump 150LivaNova Deutschland GmbH"Inserts 1/8"" x 1/16"""2015-10-16
04033817900252S5 Roller Pump 150LivaNova Deutschland GmbH"Inserts 3/16"" x 1/16"""2015-10-20
04033817900269S5 Roller Pump 150LivaNova Deutschland GmbH"Inserts 1/4"" x 1/16"""2015-10-20
04033817900276S5 Roller Pump 150LivaNova Deutschland GmbH"Inserts 1/4"" x 3/32"""2015-10-14
04033817900283S5 Roller Pump 150LivaNova Deutschland GmbH"Inserts 3/8"" x 1/16"""2015-10-14
04033817900290S5 Roller Pump 150LivaNova Deutschland GmbH"Inserts 3/8"" x 3/32"""2015-10-20
04033817900306S5 Roller Pump 150LivaNova Deutschland GmbH"Inserts 1/2"" x 1/16"""2015-10-16
04033817900313S5 Roller Pump 150LivaNova Deutschland GmbH"Inserts 1/2"" x 3/32"""2015-10-14
04033817900320S5 Roller Pump 150LivaNova Deutschland GmbHInserts Cardioplegia 1:12015-10-20
04033817900337S5 Roller Pump 150LivaNova Deutschland GmbHInserts Cardioplegia 1:12015-10-19
04033817900344S5 Roller Pump 150LivaNova Deutschland GmbHInserts Cardioplegia 2:12015-10-14
04033817900351S5 Roller Pump 150LivaNova Deutschland GmbHInserts Cardioplegia 2:12015-10-19
04033817900368S5 Roller Pump 150LivaNova Deutschland GmbHInserts Cardioplegia 4:12015-10-16
04033817900375S5 Roller Pump 150LivaNova Deutschland GmbHInserts Cardioplegia 8:12015-10-14
04033817900382S5 Roller Pump 150LivaNova Deutschland GmbHRP 1502015-10-14
04033817900399VariolockLivaNova Deutschland GmbHTubing Clamp RP1502015-10-14
04033817900405S5 Double Roller Pump 85LivaNova Deutschland GmbHDRP 852015-10-20
04033817900412S5 Double Roller Pump 85LivaNova Deutschland GmbH"Inserts 1/8"" x 1/16"""2015-10-14
04033817900429S5 Double Roller Pump 85LivaNova Deutschland GmbH"Inserts 1/4"" x 1/16"""2015-10-20
04033817900436S5 Double Roller Pump 85LivaNova Deutschland GmbH"Inserts 1/4"" x 3/32"""2015-10-14
04033817900443S5 Double Roller Pump 85LivaNova Deutschland GmbH"Inserts 5/16"" x 3/32"""2015-10-16
04033817900450S5 Double Roller Pump 85LivaNova Deutschland GmbH"Inserts 3/16"" x 1/16"""2015-10-14
04033817900467S5 Double Roller Pump 85LivaNova Deutschland GmbH"Inserts 3/32"" x 1/16"""2015-10-14
04033817900474S5 Mast Roller PumpLivaNova Deutschland GmbHMRP 1502015-10-14
04033817900481S5 Mast Roller PumpLivaNova Deutschland GmbHMRP 852015-10-14
04033817900498Venous Line ClampLivaNova Deutschland GmbHwith Remote Control2015-10-14
04033817900504EVOLivaNova Deutschland GmbHOccluder2015-10-14
04033817900535S5 ConsoleLivaNova Deutschland GmbHIce Container2015-10-20
04033817900542Temperature MonitorLivaNova Deutschland GmbHSensor Module (SCPC)2015-10-20