FDA.reportPublic FDA data

COM.TEC

Primary DI
04086000860154
Brand
COM.TEC
Company
Fresenius Kabi AG
Model
9008031
Catalog number
9008031
Device description
The COM.TEC Blood Cell Separator is a blood cell separator which utilizes centrifugal force as the basis for operation. The fields of application are as follows:- Plasma exchange- Plasma treatment
Published
2016-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
K060734000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K060734000FRESENIUS COM.TEC AUTOMATED CELL SEPARATOR, MODEL 9008031; FRESENIUS C5L, S5L, C5L-T PLATELET SETS (5-DAY STORAGE)Fresenius Medical Care North America2006-09-05LKN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04086000860154PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04086000860154040860008601544086000860154

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).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4916726868436dieter.fries@fresenius-kabi.co
+4916726868436dieter.fries@fresenius-kabi.com

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
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
04086000901550TPE Plasma Exchange SetFresenius Kabi AGLKN2016-09-16
05020583103108Spectra Optia®TERUMO BCT, INC.LKN2016-09-15
05020583610002Spectra Optia®TERUMO BCT, INC.LKN2016-09-15
04086000100151AMICUS Exchange KitFresenius Kabi AGLKN2016-09-05
04086000100168Blood Component Filter Set with Vented Spike and Luer AdapterFresenius Kabi AGLKN2016-09-05