AMICUS Separator Software

GUDID 04086000101660

Software version for Amicus Separator.

Fresenius Kabi AG

Apheresis system
Primary Device ID04086000101660
NIH Device Record Key131de1aa-b74e-4622-9ab5-15bc9b6ea583
Commercial Distribution StatusIn Commercial Distribution
Brand NameAMICUS Separator Software
Version Model Number5.12
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
GS104086000101660 [Primary]

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 Number2
Public Version Date2018-03-29
Device Publish Date2017-11-14

On-Brand Devices [AMICUS Separator Software]

04086000101660Software version for Amicus Separator.
04086000101653Software version for Amicus Separator.
04086000101912Software version for Amicus Separator

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