AMICUS Separator Legacy Software

GUDID 00810020440591

Software version for AMICUS Separator Legacy Device

Fresenius Kabi AG

Apheresis system
Primary Device ID00810020440591
NIH Device Record Key5f8f0266-3d91-48dc-840a-a3889df4f883
Commercial Distribution StatusIn Commercial Distribution
Brand NameAMICUS Separator Legacy Software
Version Model Number6.1.13.0
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 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
GS100810020440591 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-04-04
Device Publish Date2024-03-27

On-Brand Devices [AMICUS Separator Legacy Software]

00810020441208Software version for AMICUS Separator Legacy Device
00810020440591Software version for AMICUS Separator Legacy Device

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