FDA.reportPublic FDA data

Fenwal AMICUS RBC Set w/SEPACELL R-3000 RBC Leukocyte Reduction Filter

Primary DI
M5264C23041
Brand
Fenwal AMICUS RBC Set w/SEPACELL R-3000 RBC Leukocyte Reduction Filter
Company
Fresenius Kabi AG
Model
4C2304
Catalog number
4C2304
Device description
For Filtration and Storage of One Unit of ACD-A/ADSOL Red Blood Cells. Sterile Fluid Path.
Published
2017-02-18
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
GKTSeparator, Automated, Blood Cell, Diagnostic

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
BK0000390

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BK0000390

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M5264C23043PackageHIBCC6
M5264C23041PrimaryHIBCC0
M5264C23040Unit of UseHIBCC0

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 Controlled Room Temperature. Protect from freezing. Avoid excessive heat.

Regulatory Flags#

DUNS number
315654579
Device count
3
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

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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
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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
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04086000100090AMICUS Apheresis Kit – Single NeedleX6R2312X6R23122025-11-03
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