Aurora Xi Plasmapheresis System

GUDID 04086000101967

Aurora Xi Plasmapheresis System Software Version 1.2

Fresenius Kabi AG

Apheresis system
Primary Device ID04086000101967
NIH Device Record Key0e3d9fb3-0c6a-424c-b386-f3be484e6e9e
Commercial Distribution StatusIn Commercial Distribution
Brand NameAurora Xi Plasmapheresis System
Version Model Number1.2
Company DUNS315654579
Company NameFresenius Kabi AG
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
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
GS104086000101967 [Primary]

FDA Product Code

GKTSeparator, Automated, Blood Cell, Diagnostic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-01-14
Device Publish Date2018-12-12

On-Brand Devices [Aurora Xi Plasmapheresis System]

04086000101967Aurora Xi Plasmapheresis System Software Version 1.2
04086000101523For collection of plasma by membrane filtration.For Use With the Plasmacell Xi Disposable Sets.
00810020440898Software Version 1.3 for Aurora Xi

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