FDA.report

Apheresis system

Definition
An assembly of electrically-powered devices designed for the extracorporeal separation and removal of a constituent of whole blood (e.g., plasma, platelets, leukocytes) and pathogens, and the return of the remaining constituents to the patient. It typically includes pumps to circulate the blood and uses methods such as membrane filtration, centrifugation, adsorption, or a combination of these to separate the constituent from the blood. The system may be used therapeutically (e.g., to remove immune complexes or low density lipoproteins) or for the harvesting of blood constituents (e.g., for HLA-matched platelets or fresh frozen plasma).
GUDID devices
53
Last updated
2026-03-19 21:56:45

Related Product Codes

CodeDeviceSpecialtyClassDevices
GKTSeparator, Automated, Blood Cell, DiagnosticHematology236
HNASpud, OphthalmicOphthalmic16
ORGPlatelet And Plasma Separator For Bone Graft HandlingHematology26
LKNSeparator, Automated, Blood Cell And Plasma, TherapeuticUnknownU1
MHWDressing, CompressionGeneral Hospital11
MMYLipoprotein, Low Density, RemovalUnknown31
OUGMedical Device Data SystemGeneral Hospital11
PBNApheresis For Focal Glomerulosclerosis In Adult And Pediatric PatientsUnknownf1

Representative GUDID Devices

Primary DIBrandCompanyModelPublished
00811137013104Amicus SeparatorFresenius Kabi AG6R4590R2026-03-11
00810020440560Aurora XiFresenius Kabi AGSoftware Version 2.12025-02-26
00810020442199Aurora XiFresenius Kabi AGSoftware Version 2.02025-02-26
08809410200008Dr.PRPRmedica Co.,LtdDr.PRP RMLB-008(1)2025-01-03
08809410200060Dr.PRPRmedica Co.,LtdDr.PRP RMLB-008(1)2025-01-03
00810020440591AMICUS Separator Legacy SoftwareFresenius Kabi AG6.1.13.02024-03-27
00810020440607AMICUS Separator Life Extension SoftwareFresenius Kabi AG6.1.113.02024-03-27
00810020441192AMICUS Separator Life Extension SoftwareFresenius Kabi AG6.12023-05-24
00810020441208AMICUS Separator Legacy SoftwareFresenius Kabi AG6.12023-05-23
00810020440898Aurora Xi Plasmapheresis SystemFresenius Kabi AG1.32023-02-17
30812747012861MCS 9000HAEMONETICS CORPORATION09000-220-ED2023-02-07
05020583420007Rika Plasma Donation SystemTERUMO BCT, INC.420002022-07-13
00810020440676Aurora Xi Plasmapheresis SystemFresenius Kabi AG6R4612R2022-02-11
00810020440300Aurora Software Version 2.1C UpgradeFresenius Kabi AGVersion 2.1C2021-06-09
00810020440218AMICUS SeparatorFresenius Kabi AG6R45902021-02-09
00810020440249AMICUS SeparatorFresenius Kabi AG6R4590TH-M2021-02-09
00810020440232AMICUS SeparatorFresenius Kabi AG6R4590TH-T2020-10-20
00810799031358Stephens InstrumentsKRISHNA IMPORTS INCS2-11312020-09-22
00810799031365Stephens InstrumentsKRISHNA IMPORTS INCS2-11352020-09-22
00810799031372Stephens InstrumentsKRISHNA IMPORTS INCS2-11402020-09-22
00810799031389Stephens InstrumentsKRISHNA IMPORTS INCS2-11452020-09-22
00810799031396Stephens InstrumentsKRISHNA IMPORTS INCS2-11502020-09-22
00810799031402Stephens InstrumentsKRISHNA IMPORTS INCS2-11552020-09-22
10810041981636VIVEVIVE HEALTH LLCSUP20182020-03-18
04086000101912AMICUS Separator SoftwareFresenius Kabi AG6.02020-01-21
00810020440003Aurora Plasmapheresis System Software Version 2.1Fresenius Kabi AGSW 2.12019-10-25
04046964337017B.BRAUNB.Braun Avitum AG706210A2014-09-15
30812747012816HAEMONETICS MCS+ (LN9000) APHERESIS SYSTEMHAEMONETICS CORPORATION09000-110-E2017-02-06
30812747012854HAEMONETICS MCS+ (LN9000) APHERESIS SYSTEMHAEMONETICS CORPORATION09000-220-E2017-02-06
30812747012878HAEMONETICS MCS+ (LN9000) APHERESIS SYSTEMHAEMONETICS CORPORATION09000-220-EW2017-02-06
30812747013851MCS+HAEMONETICS CORPORATION08150-220-E2017-02-06
30812747013875MCS+HAEMONETICS CORPORATION08150-110-E2017-02-06
04086000100120AMICUS SeparatorFresenius Kabi AG6R45802016-09-02
04086000100137AMICUS SeparatorFresenius Kabi AG6R4580R2016-09-02
04086000100212ALYX Component Collection SystemFresenius Kabi AG6R57252016-09-08
04086000100236Aurora Plasmapheresis SystemFresenius Kabi AG6R46012016-09-05
04086000101059Aurora Software Version 1.3 Upgrade KitFresenius Kabi AG6R20132016-09-22
04086000101516Aurora Xi SoftwareFresenius Kabi AG1.12017-12-18
04086000101523Aurora Xi Plasmapheresis SystemFresenius Kabi AG6R46122017-03-02
04086000101653AMICUS Separator SoftwareFresenius Kabi AG5.1212017-11-14
04086000101660AMICUS Separator SoftwareFresenius Kabi AG5.122017-11-14
04086000101967Aurora Xi Plasmapheresis SystemFresenius Kabi AG1.22018-12-12
04086000860154COM.TECFresenius Kabi AG90080312016-09-16
04987671040374APHERESIS MACHINEKANEKA PHARMA AMERICA LLCKANEKA MA-032014-09-25
05020583610002Spectra Optia®TERUMO BCT, INC.610002016-09-15
05020583810006Trima Accel® TERUMO BCT, INC.810002016-09-15
05020583810013Trima Accel® TERUMO BCT, INC.810012016-09-15
05020583810020Trima Accel® TERUMO BCT, INC.810022016-09-15
05020583940109TRIMA ACCEL PROCEDURE SUMMARY (TAPS) INTERFACETERUMO BCT, INC.940102016-09-15
00852714003057Angel Whole Blood Processing SystemNUO THERAPEUTICS INC9760001002016-09-19
00852714003064Angel Whole Blood Processing SystemNUO THERAPEUTICS INC9760009002016-09-19
00852714003071Angel Whole Blood Processing SystemNUO THERAPEUTICS INC9760001012016-09-19
00852714003088Angel Whole Blood Processing System Machine - EU - ReworkedNUO THERAPEUTICS INC9760009012016-09-19