FDA.reportPublic FDA data

Leukoconnect

Primary DI
04052682004308
Brand
Leukoconnect
Company
Fresenius Kabi AG
Model
4C4300
Catalog number
4C4300
Device description
LeukoConnect - Pre-Storage Sterile Connect Leukoreduction Set with Sepacell RS-2000 Filter for Red Blood Cells in Additive Solution
Published
2022-06-02
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
CAKMicrofilter, Blood Transfusion

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CAKMicrofilter, Blood TransfusionGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
BK0200080

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BK0200080

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14052682004305PackageGS130In Commercial Distribution
00811137010486PreviousGS10
04052682004308PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1405268200430514052682004305
00811137010486008111370104868111370104860811137010486
04052682004308040526820043084052682004308

GMDN Terms#

Term, Definition table
TermDefinition
Blood transfer setA collection of sterile, flexible, plastic tubing and associated items (e.g., couplers, adapters, clamps) used to transfer blood or blood components (e.g., peripheral stem cells, plasma) into containers or between containers for processing or storage (e.g., freezing). 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.

Regulatory Flags#

DUNS number
315654579
Device count
1
Lot or batch
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
10810197810460GVSGvs Tm, Inc.CAK2026-02-19
20810197810467GVSGvs Tm, Inc.CAK2026-02-19
10810197810170GVSGvs Tm, Inc.CAK2026-01-19
20810197810177GVSGvs Tm, Inc.CAK2026-01-19
14052682004305LeukoconnectFresenius Kabi AGCAK2022-06-02
10887691000178HaemoneticsHAEMONETICS CORPORATIONCAK2022-03-15
10887691000543HaemoneticsHAEMONETICS CORPORATIONCAK2022-03-15
30887691000172HaemoneticsHAEMONETICS CORPORATIONCAK2022-03-15
30887691000547HaemoneticsHAEMONETICS CORPORATIONCAK2022-03-15
10887691000666HaemoneticsHAEMONETICS CORPORATIONCAK2021-03-19
30887691000660HaemoneticsHAEMONETICS CORPORATIONCAK2021-03-19
20887691308745Leukocyte SC RCHAEMONETICS CORPORATIONCAK2017-06-16
30887691308742Leukocyte SC RCHAEMONETICS CORPORATIONCAK2017-06-16
10887691000673HaemoneticsHAEMONETICS CORPORATIONCAK2017-02-06
10887691305792HaemoneticsHAEMONETICS CORPORATIONCAK2017-02-06
30887691000677HaemoneticsHAEMONETICS CORPORATIONCAK2017-02-06
30887691305796HaemoneticsHAEMONETICS CORPORATIONCAK2017-02-06
10887691000550PXL 8HAEMONETICS CORPORATIONCAK2017-02-02
10887691000581RCXL1HAEMONETICS CORPORATIONCAK2017-02-02
10887691000680HaemoneticsHAEMONETICS CORPORATIONCAK2017-02-02
30887691000554PXL 8HAEMONETICS CORPORATIONCAK2017-02-02
30887691000585RCXL1HAEMONETICS CORPORATIONCAK2017-02-02
30887691000684HaemoneticsHAEMONETICS CORPORATIONCAK2017-02-02
10887691000758HaemoneticsHAEMONETICS CORPORATIONCAK2017-01-19
10887691001243LipiGuard SBHAEMONETICS CORPORATIONCAK2017-01-19
10887691304214Haemonetics Leukotrap SC RCHAEMONETICS CORPORATIONCAK2017-01-19
10887691305303HaemoneticsHAEMONETICS CORPORATIONCAK2017-01-19
30887691000752HaemoneticsHAEMONETICS CORPORATIONCAK2017-01-19
30887691001247LipiGuard SBHAEMONETICS CORPORATIONCAK2017-01-19
30887691304218Haemonetics Leukotrap SC RCHAEMONETICS CORPORATIONCAK2017-01-19