FDA.reportPublic FDA data

AMICUS Exchange Kit

Primary DI
04086000100151
Brand
AMICUS Exchange Kit
Company
Fresenius Kabi AG
Model
X6R2339
Catalog number
X6R2339
Device description
For Therapeutic Plasma Exchange (TPE) Procedure. For Use with the AMICUS Separator. Sterile Fluid Path.
Published
2016-09-05
Public version status
Update
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
LKNSeparator, Automated, Blood Cell And Plasma, Therapeutic

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K111702000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K111702000AMICUS SEPARATOR SYSTEM- USE IN THERAPEUTIC PLASMA EXCHANGE AND FILTER SET FOR AMICUS TPEFenwal, Inc.2012-03-22LKN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14086000100158PackageGS16In Commercial Distribution
04086000100151PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1408600010015814086000100158
04086000100151040860001001514086000100151

GMDN Terms#

Term, Definition table
TermDefinition
Therapeutic plasma/red blood cell exchange tubing setA disposable collection of devices intended to be used in a therapeutic plasma exchange (TPE) or red blood cell exchange system. It typically consists of tubing, solution lines, connection ports, a filter membrane and collection containers (bags) to channel blood from the patient through the extracorporeal circuit to remove a disease-mediating blood component. The blood is returned to the patient with any substitution products. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store at Room Temperature. Protect from freezing. Avoid excessive heat.

Sterilization Methods#

Method table
Method

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
00811505030573IvenixSET-0040-1SET-0040-12026-06-02
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810020440591AMICUS Separator Legacy SoftwareFresenius Kabi AGLKN2024-03-27
00810020440607AMICUS Separator Life Extension SoftwareFresenius Kabi AGLKN2024-03-27
00810020441192AMICUS Separator Life Extension SoftwareFresenius Kabi AGLKN2023-05-24
00810020441208AMICUS Separator Legacy SoftwareFresenius Kabi AGLKN2023-05-23
05020583707009COBE® Spectra TERUMO BCT, INC.LKN2021-06-07
05020583909014COBE® 2991 TERUMO BCT, INC.LKN2021-06-07
05020583909045COBE® 2991 TERUMO BCT, INC.LKN2021-06-07
05020583909120COBE® 2991 TERUMO BCT, INC.LKN2021-06-07
35020583707000COBE® Spectra TERUMO BCT, INC.LKN2021-06-07
35020583909015COBE® 2991 TERUMO BCT, INC.LKN2021-06-07
35020583909046COBE® 2991 TERUMO BCT, INC.LKN2021-06-07
35020583909121COBE® 2991 TERUMO BCT, INC.LKN2021-06-07
05020583102200Spectra Optia® TERUMO BCT, INC.LKN2021-05-05
00810020440218AMICUS SeparatorFresenius Kabi AGLKN2021-02-09
00810020440249AMICUS SeparatorFresenius Kabi AGLKN2021-02-09
00810020440171AMICUS Separator Life Extension SoftwareFresenius Kabi AGLKN2020-11-18
00810020440232AMICUS SeparatorFresenius Kabi AGLKN2020-10-20
04086000101912AMICUS Separator SoftwareFresenius Kabi AGLKN2020-01-21
04052682031717Blood Component Filter Set with Vented Spike and Luer AdapterFresenius Kabi AGLKN2019-02-20
04052682031724Waste Transfer SetFresenius Kabi AGLKN2019-02-20
04086000101950AMICUS Exchange Kit - TherapeuticsFresenius Kabi AGLKN2019-02-20
10812747012072HAEMONETICS MCS+ (LN9000) APHERESIS SYSTEMHAEMONETICS CORPORATIONLKN2017-02-08
10812747012089HAEMONETICS MCS+ (LN9000) APHERESIS SYSTEMHAEMONETICS CORPORATIONLKN2017-02-08
04086000901543TPE Plasma Exchange SetFresenius Kabi AGLKN2016-09-16
04052682003721P1R Plasma Treatment SetFresenius Kabi AGLKN2016-09-16
04086000860154COM.TECFresenius Kabi AGLKN2016-09-16
04086000901550TPE Plasma Exchange SetFresenius Kabi AGLKN2016-09-16
05020583103108Spectra Optia®TERUMO BCT, INC.LKN2016-09-15
05020583610002Spectra Optia®TERUMO BCT, INC.LKN2016-09-15
04086000100168Blood Component Filter Set with Vented Spike and Luer AdapterFresenius Kabi AGLKN2016-09-05