FDA.reportPublic FDA data

Amicus MNC Apheresis Kit - Double Needle

Primary DI
00810020442229
Brand
Amicus MNC Apheresis Kit - Double Needle
Company
Fresenius Kabi AG
Model
X7R2326SB
Catalog number
X7R2326SB
Device description
For Mononuclear Cell (MNC) Collection. For use with the Amicus Separator.
Published
2026-02-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GKTSeparator, Automated, Blood Cell, Diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GKTSeparator, Automated, Blood Cell, DiagnosticHematology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
01081002044222PackageGS16In Commercial Distribution
00810020442229PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
01081002044222010810020442221081002044222
00810020442229008100204422298100204422290810020442229

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store at Room Temperature.

Regulatory Flags#

DUNS number
315654579
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00811137013012Aurora Xi611259237861125923782026-08-08
00811505030573IvenixSET-0040-1SET-0040-12026-06-02
00811137013104Amicus Separator6R4590R6R4590R2026-03-11
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00811137013012Aurora XiFresenius Kabi AGGKT2026-08-08
10812747019859Haemonetics® NexSys PCS® SystemHAEMONETICS CORPORATIONGKT2026-03-20
30812747019853Haemonetics® NexSys PCS® SystemHAEMONETICS CORPORATIONGKT2026-03-20
00811137013104Amicus SeparatorFresenius Kabi AGGKT2026-03-11
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
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
05020583910003COBE® 2991 TERUMO BCT, INC.GKT2023-06-19
00810020441192AMICUS Separator Life Extension SoftwareFresenius Kabi AGGKT2023-05-24