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Fresenius Kabi USA, LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30147321573014732157Fresenius Kabi USA, LLC1N2026-01-0150 High Street Suite 50 North Andover MA US 01845
13211163001833549Fresenius Kabi USA, LLC1N2020-04-253159 STALEY RD. GRAND ISLAND NY US 14072
30027339563002733956Fresenius Kabi USA, LLC1N2020-04-253 CORPORATE DR STE 300 Lake Zurich IL US 60047

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3054231366991501K213089Ivenix Infusion System, LVP Epidural Administraion Set NRFit ConnectorFPA2021-11-10
3054231202960113K183311Ivenix Infusion System (IIS)FRN2019-06-07
178171916895131K092938HEPARIN LOCK FLUSH SOLUTION USP, MODELS 504401, 504411, 504505, 505701, 504901, 1710NZW2010-06-18
178191916895131K092938HEPARIN LOCK FLUSH SOLUTION USP, MODELS 504401, 504411, 504505, 505701, 504901, 1710NZW2010-06-18

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
NZW22010-06-18
FPA12021-11-10
FRN12019-06-07

NDC#

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