Aurora Plasmapheresis System 6R4601

GUDID 04086000100236

Automated plasmapheresis system designed to collect virtually cell-free plasma by membrane filtration using single-use disposable sets. Collected plas

Fresenius Kabi AG

Apheresis system
Primary Device ID04086000100236
NIH Device Record Key2b41ab1c-ca0c-4d6d-8c55-54eb29e3c6cd
Commercial Distribution StatusIn Commercial Distribution
Brand NameAurora Plasmapheresis System
Version Model Number6R4601
Catalog Number6R4601
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
GS104086000100236 [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 Date2016-09-05

Devices Manufactured by Fresenius Kabi AG

14086000100059 - AMICUS Apheresis Kit – Single Needle with Platelet Additive Solution Connector2024-11-07 For Collection of Platelets with Optional Plasma and/or Red Blood Cells. For Platelet Storage in Plasma or Platelet Additive Sol
04086000860888 - COMPOGUARD Advance Basic2024-11-07 Device, Blood Mixing and Weighing
04086000860895 - COMPOGUARD Advance Data2024-11-06 Device, Blood Mixing and Weighing
04086000860901 - COMPOGUARD Advance COMPLETE2024-11-06 Device, Blood Mixing and Weighing
00810020440591 - AMICUS Separator Legacy Software2024-04-04 Software version for AMICUS Separator Legacy Device
00810020440607 - AMICUS Separator Life Extension Software2024-04-04 Software version for AMICUS Separator Life Extension Device
04250273750164 - Volumat™ Line2024-03-29 IV administration set for infusion pumps
04250273750218 - Volumat™ Line2024-03-29 IV administration set for infusion pumps

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.