VOLUMAT MC AGILIA US Z021135

GUDID 04086000851794

The VOLUMAT MC AGILIA US is a transportable equipment intended to be used in healthcare facilities environment by healthcare trained professionals, ac

Fresenius Kabi AG

General-purpose infusion pump, line-powered
Primary Device ID04086000851794
NIH Device Record Key29b5df1c-f6db-494c-848b-e2adb61bb34c
Commercial Distribution StatusIn Commercial Distribution
Brand NameVOLUMAT MC AGILIA US
Version Model NumberZ021135
Catalog NumberZ021135
Company DUNS315654579
Company NameFresenius Kabi AG
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
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 Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+33476672358
Emailmarie-pierre.pruneau@fresenius
Phone+33476672358
Emailmarie-pierre.pruneau@fresenius-kabi.com
Phone+33476672358
Emailmarie-pierre.pruneau@fresenius-kabi.com
Phone+33476672358
Emailmarie-pierre.pruneau@fresenius-kabi.com
Phone+33476672358
Emailmarie-pierre.pruneau@fresenius-kabi.com
Phone+33476672358
Emailmarie-pierre.pruneau@fresenius-kabi.com
Phone+33476672358
Emailmarie-pierre.pruneau@fresenius-kabi.com
Phone+33476672358
Emailmarie-pierre.pruneau@fresenius-kabi.com
Phone+33476672358
Emailmarie-pierre.pruneau@fresenius-kabi.com
Phone+33476672358
Emailmarie-pierre.pruneau@fresenius-kabi.com
Phone+33476672358
Emailmarie-pierre.pruneau@fresenius-kabi.com
Phone+33476672358
Emailmarie-pierre.pruneau@fresenius-kabi.com
Phone+33476672358
Emailmarie-pierre.pruneau@fresenius-kabi.com
Phone+33476672358
Emailmarie-pierre.pruneau@fresenius-kabi.com
Phone+33476672358
Emailmarie-pierre.pruneau@fresenius-kabi.com
Phone+33476672358
Emailmarie-pierre.pruneau@fresenius-kabi.com
Phone+33476672358
Emailmarie-pierre.pruneau@fresenius-kabi.com
Phone+33476672358
Emailmarie-pierre.pruneau@fresenius-kabi.com
Phone+33476672358
Emailmarie-pierre.pruneau@fresenius-kabi.com
Phone+33476672358
Emailmarie-pierre.pruneau@fresenius-kabi.com
Phone+33476672358
Emailmarie-pierre.pruneau@fresenius-kabi.com
Phone+33476672358
Emailmarie-pierre.pruneau@fresenius-kabi.com
Phone+33476672358
Emailmarie-pierre.pruneau@fresenius-kabi.com
Phone+33476672358
Emailmarie-pierre.pruneau@fresenius-kabi.com
Phone+33476672358
Emailmarie-pierre.pruneau@fresenius-kabi.com
Phone+33476672358
Emailmarie-pierre.pruneau@fresenius-kabi.com
Phone+33476672358
Emailmarie-pierre.pruneau@fresenius-kabi.com
Phone+33476672358
Emailmarie-pierre.pruneau@fresenius-kabi.com
Phone+33476672358
Emailmarie-pierre.pruneau@fresenius-kabi.com
Phone+33476672358
Emailmarie-pierre.pruneau@fresenius-kabi.com

Device Identifiers

Device Issuing AgencyDevice ID
GS104086000851794 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

FRNPump, Infusion

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 Date2017-09-29

Devices Manufactured by Fresenius Kabi AG

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00810020440560 - Aurora Xi2025-03-06 Aurora Xi Plasmapheresis System with Software Version 2.1
00810020442199 - Aurora Xi2025-03-06 Aurora Xi Plasmapheresis System with Software Version 2.0
10810020441380 - Plasmalink Bottle 1000 mL with locking luer adapter2025-01-23 For the collection of blood components. Sterile Fluid Path
10810020440512 - Adaptive Nomogram Transfer Pack2024-12-20 For processing and/or storage of blood and blood components. Sterile Fluid Path
00811505030450 - Ivenix Infusion System2024-12-16 Infusion Management System (IMS)
00811505030467 - Ivenix Infusion System2024-12-16 Large Volume Pump (LVP) Software (order 1 per pump)
14086000100059 - AMICUS Apheresis Kit – Single Needle with Platelet Additive Solution Connector2024-11-07 For Collection of Platelets with Optional Plasma and/or Red Blood Cells. For Platelet Storage in Plasma or Platelet Additive Sol

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