FDA.reportPublic FDA data

AMICUS Separator

Primary DI
00810020440249
Brand
AMICUS Separator
Company
Fresenius Kabi AG
Model
6R4590TH-M
Catalog number
6R4590TH-M
Device description
The AMICUS Separator is an automated blood cell separator indicated for the collection of blood components and in therapeutic apheresis.
Published
2021-02-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GKTSeparator, Automated, Blood Cell, Diagnostic
LKNSeparator, Automated, Blood Cell And Plasma, Therapeutic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GKTSeparator, Automated, Blood Cell, DiagnosticHematology2
LKNSeparator, Automated, Blood Cell And Plasma, TherapeuticUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200530000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200530000AMICUS Separator SystemFresenius Kabi AG2020-09-11GKT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810020440249PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810020440249008100204402498100204402490810020440249

GMDN Terms#

Term, Definition table
TermDefinition
Apheresis systemAn 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).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify000° C (32° F) and 50° C (122° F) with a relative humidity less than 85% at 40° C (104° F).
Special Storage Condition, Specify00Shipping Carton Label has symbols/definitions for Temperature Limit and Relative Humidity. OPM Volume 1 states: The AMICUS separator can be stored for up to six months at a temperature between

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
315654579
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00811137013104Amicus Separator6R4590R6R4590R2026-03-11
00810020442229Amicus MNC Apheresis Kit - Double NeedleX7R2326SBX7R2326SB2026-02-03
01081002044222Amicus MNC Apheresis Kit - Double NeedleX7R2326SBX7R2326SB2026-02-03
04086000860888COMPOGUARD Advance Basic902974190297412024-10-30
04086000860895COMPOGUARD Advance Data902975190297512024-10-29
04086000860901COMPOGUARD Advance COMPLETE902976190297612024-10-29
04086000860741CompoGuard Basic (NA)902964190296412022-11-10
04086000860758CompoGuard Data (NA)902965190296512022-11-10
04086000860765CompoGuard Complete (NA)902966190296612022-11-10
04086000100199ALYX 2RBC LR KITX4R5720X4R57202018-02-14
04086000100991Fenwal AMICUS Apheresis Kit - Single Needle Functionally Closed4R23674R23672016-09-09
04086000100984Fenwal AMICUS Apheresis Kit - Double Needle Functionally Closed4R23654R23652016-09-09
00810020440164AMICUS Single Needle Advanced Kit with 20 mL Platelet Sampling System Assembly4R2353G4R2353G2020-10-20
04086000101370Fenwal AMICUS Single Needle Advanced Kit4R23534R23532016-09-02
04086000101387Fenwal AMICUS Double Needle Advanced Kit4R23544R23542016-09-02
00810020440140AMICUS Double Needle Advanced Kit with 20 mL Platelet Sampling System Assembly4R2354G4R2354G2020-10-20
04086000101332Fenwal AMICUS Apheresis Kit - Double Needle4R23554R23552016-09-09
04086000101349Fenwal AMICUS Apheresis Kit - Single Needle4R23574R23572016-09-09
04086000100090AMICUS Apheresis Kit – Single NeedleX6R2312X6R23122025-11-03
00810020441062Fenwal Hand Sealer4R4454W4R4454W2025-04-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10812747019859Haemonetics® NexSys PCS® SystemHAEMONETICS CORPORATIONGKT2026-03-20
30812747019853Haemonetics® NexSys PCS® SystemHAEMONETICS CORPORATIONGKT2026-03-20
00811137013104Amicus SeparatorFresenius Kabi AGGKT2026-03-11
00810020442229Amicus MNC Apheresis Kit - Double NeedleFresenius Kabi AGGKT2026-02-03
01081002044222Amicus MNC Apheresis Kit - Double NeedleFresenius Kabi AGGKT2026-02-03
04086000100090AMICUS Apheresis Kit – Single NeedleFresenius Kabi AGGKT2025-11-03
00810020440560Aurora XiFresenius Kabi AGGKT2025-02-26
00810020442199Aurora XiFresenius Kabi AGGKT2025-02-26
04086000100052AMICUS Apheresis Kit – Single Needle with Platelet Additive Solution ConnectorFresenius Kabi AGGKT2024-10-30
14086000100059AMICUS Apheresis Kit – Single Needle with Platelet Additive Solution ConnectorFresenius Kabi AGGKT2024-10-30
10812747019279Haemonetics® PCS®2 & NexSys PCS® SystemsHAEMONETICS CORPORATIONGKT2024-07-19
10812747019347Haemonetics® PCS®2 & NexSys PCS® SystemsHAEMONETICS CORPORATIONGKT2024-07-19
30812747019273Haemonetics® PCS®2 & NexSys PCS® SystemsHAEMONETICS CORPORATIONGKT2024-07-19
30812747019341Haemonetics® PCS®2 & NexSys PCS® SystemsHAEMONETICS CORPORATIONGKT2024-07-19
10812747019736Haemonetics® NexSys PCS® SystemHAEMONETICS CORPORATIONGKT2024-07-17
30812747019730Haemonetics® NexSys PCS® SystemHAEMONETICS CORPORATIONGKT2024-07-17
00810020440591AMICUS Separator Legacy SoftwareFresenius Kabi AGGKT2024-03-27
00810020440591AMICUS Separator Legacy SoftwareFresenius Kabi AGLKN2024-03-27
00810020440607AMICUS Separator Life Extension SoftwareFresenius Kabi AGLKN2024-03-27
00810020440607AMICUS Separator Life Extension SoftwareFresenius Kabi AGGKT2024-03-27
00810020441635Amicus Apheresis Kit - Functionally Closed Single Needle with PAS Spike and DualFresenius Kabi AGGKT2024-01-24
00810020441642Amicus Apheresis Kit - Functionally Closed Double Needle with PAS Spike and DualFresenius Kabi AGGKT2024-01-24
10810020441632Amicus Apheresis Kit - Functionally Closed Single Needle with PAS Spike and DualFresenius Kabi AGGKT2024-01-24
10810020441649Amicus Apheresis Kit - Functionally Closed Double Needle with PAS Spike and DualFresenius Kabi AGGKT2024-01-24
04086000101035ALYX 2RBC-LR Kit with Saline SpikeFresenius Kabi AGGKT2023-12-13
14086000101032ALYX 2RBC-LR Kit with Saline SpikeFresenius Kabi AGGKT2023-12-13
10812747019330Haemonetics® NexSys PCS® SystemHAEMONETICS CORPORATIONGKT2023-06-29
30812747019334Haemonetics® NexSys PCS® SystemHAEMONETICS CORPORATIONGKT2023-06-29
05020583826502Trima AccelTERUMO BCT, INC.GKT2023-06-19
35020583826503Trima AccelTERUMO BCT, INC.GKT2023-06-19