AMICUS Separator 6R4580R

GUDID 04086000100137

Automated blood cell separator indicated for the collection of blood components and in therapeutic apheresis.

Fresenius Kabi AG

Apheresis system
Primary Device ID04086000100137
NIH Device Record Keya9c53cd0-f0ca-441c-ba5b-0e41a87d4b59
Commercial Distribution StatusIn Commercial Distribution
Brand NameAMICUS Separator
Version Model Number6R4580R
Catalog Number6R4580R
Company DUNS315654579
Company NameFresenius Kabi AG
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104086000100137 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GKTSeparator, Automated, Blood Cell, Diagnostic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-02

On-Brand Devices [AMICUS Separator]

04086000100137Automated blood cell separator indicated for the collection of blood components and in therapeut
04086000100120Automated blood cell separator indicated for the collection of blood components and in therapeut
00810020440232The AMICUS Separator is an automated blood cell separator indicated for the collection of blood
00810020440249The AMICUS Separator is an automated blood cell separator indicated for the collection of blood
00810020440218The AMICUS Separator is an automated blood cell separator indicated for the collection of blood

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