Aurora Xi Software

GUDID 04086000101516

Software version for Aurora Xi.

Fresenius Kabi AG

Apheresis system
Primary Device ID04086000101516
NIH Device Record Key81c0f603-710d-43b7-a894-02df31104688
Commercial Distribution StatusIn Commercial Distribution
Brand NameAurora Xi Software
Version Model Number1.1
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 Batchtrue
Serial Numberfalse
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
GS104086000101516 [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 Date2017-12-18

Devices Manufactured by Fresenius Kabi AG

10810020441632 - Amicus Apheresis Kit - Functionally Closed Single Needle with PAS Spike and Dual2024-02-01 For Extended Platelet Storage with Plasma and Red Blood Cell Collection. For Platelet Storage in Plasma or Platelet Additive Sol
10810020441649 - Amicus Apheresis Kit - Functionally Closed Double Needle with PAS Spike and Dual2024-02-01 For Extended Platelet Storage and Plasma Collection. For Platelet Storage in Plasma or Platelet Additive Solution Plus Plasma. F
14086000101032 - ALYX 2RBC-LR Kit with Saline Spike2023-12-21 For Collection of Two Leukoreduced Red Blood Cell Products by Centrifugation. For Use with the ALYX System. Sterile fluid path.
00810020441192 - AMICUS Separator Life Extension Software2023-06-01 Software version for AMICUS Separator Life Extension Device
00810020441208 - AMICUS Separator Legacy Software2023-05-31 Software version for AMICUS Separator Legacy Device
10810020440277 - AMICUS Apheresis Kit - Functionally Closed Single Needle with PAS Spike2023-05-30 For Extended Platelet Storage with Plasma and Red Blood Cell Collection. For Platelet Storage in Plasma or Platelet Additive Sol
10810020440765 - AMICUS Apheresis Kit - Functionally Closed Double Needle with PAS Spike2023-05-30 For Extended Platelet Storage and Plasma Collection. For Platelet Storage in Plasma or Platelet Additive Solution Plus Plasma. F
10810020441113 - PLASMACELL Xi Disposable Set with SPIKESMART2023-03-06 For Collection of Plasma by Membrane Filtration. For Use With the Aurora Xi Instrument. Sterile Fluid Path.

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