COMPOGUARD Advance COMPLETE 9029761

GUDID 04086000860901

Device, Blood Mixing and Weighing

Fresenius Kabi AG

Blood donation rocker
Primary Device ID04086000860901
NIH Device Record Key947fb947-0b30-44a6-8e32-84275e91f9eb
Commercial Distribution StatusIn Commercial Distribution
Brand NameCOMPOGUARD Advance COMPLETE
Version Model Number9029761
Catalog Number9029761
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 Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS104086000860901 [Primary]

FDA Product Code

KSQDevice, Blood Mixing And Blood Weighing

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-11-06
Device Publish Date2024-10-29

Devices Manufactured by Fresenius Kabi AG

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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 COMPLETE2024-11-06Device, 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

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