FDA.reportPublic FDA data

FRESENIUS KABI WARRENDALE

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30057784533005778453FRESENIUS KABI WARRENDALE1N2026-01-01770 Commonwealth Dr WARRENDALE PA US 15086

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1797171687706715K871198BONE MARROW COLLECTION KIT AND STANDLWE1987-11-06
1797171251520254K200530AMICUS Separator SystemGKT2020-09-11
1797171666878956K192150AMICUS Separator SystemLKN2019-11-13
1797171202960113K183311Ivenix Infusion System (IIS)FRN2019-06-07
1797171490823893K180615AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood Component Filter Set With Vented Spike and Luer AdapterLKN2018-12-04
1797171436562947K162462AMICUS Separator System, AMICUS Separator System; RefurbishedGKT2016-11-23
1797171017542021BK241135
1797171213698683BK230824
1797171278008680BK220788
1797171972462941BK200478
1797171258638614BK190368
1797172045242275BK190351
1797171780700915BK180268
1797171203598430BK170099
1797171480667983BK170072
1797171404717297BK170057
1797171739744907BK170030
1797171405681946BK170001
1797171317190992BK160042
1797171498870149BK160028
1797171715764929BK160012
1797171108663750BK150236
1797171434141742BK130030
1797171698986145BK130004
1797171028566065BK120041
1797172008876173BK110072
1797171697370601BK110025
1797171828293567BK100056
1797171647926282BK090031
1797171068354240BK080053
1797171119448276BK080024
1797171070618302BK030085
1797171811238891BK020059
1797171363736095BK020056
1797171202258100BK010033
1797171001207226
1797171271993438
1797171352877130
1797171396656618
1797171474918278
1797171642267481
1797171963350318

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GKT22020-09-11
LKN22019-11-13
FRN12019-06-07
LWE11987-11-06