FDA.reportPublic FDA data

Jennifer Masek-Little

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
80101823002807204Jennifer Masek-Little1N2026-01-01510 Lake Cook Rd Deerfield IL US 60015
80306383002806727Jennifer Masek-Little1N2026-01-01510 Lake Cook Rd Deerfield IL US 60015
96120573002806460Jennifer Masek-Little1N2026-01-01510 Lake Cook Rd Deerfield IL US 60015
96121683002806471Jennifer Masek-Little1N2026-01-01510 Lake Cook Rd Deerfield IL US 60015
96162403002807196Jennifer Masek-Little1N2026-01-01510 Lake Cook Rd Deerfield IL US 60015
30035917743003591774Jennifer Masek-Little1N2026-01-01510 Lake Cook Rd Deerfield IL US 60015
30328282993032828299Jennifer Masek-Little1N2026-01-01510 Lake Cook Rd Deerfield IL US 60015

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
186051023383322P830063GAMBRO FIBER PLASMAFILTERMDP1986-05-27
3338451655387667K961825ULTRASET/3L CAPD DISPOSABLE DISCONNECT Y-SET MODELS 5C4366 & 5C4493KDJ1996-08-06
3338451338082567K925403BAXTER APD 12' EXTENSION LINEKDJ1994-02-22
3338451625554406K923065BAXTER PERSONAL CYCLER AUTOMMATED PERITONEAL DIALFKX1994-03-04
3338451953521502K833065AUTOMATIC PERITONEAL DIALYSIS CYCLERFKX1983-11-28
3338451489274396K250508AK 98 Dialysis Machine (955607)KDI2025-08-01
186091489274396K250508AK 98 Dialysis Machine (955607)KDI2025-08-01
3338451418252250K232467CleanCart A, CleanCart C, AK 98 Hemodialysis MachineKDI2023-09-14
186091418252250K232467CleanCart A, CleanCart C, AK 98 Hemodialysis MachineKDI2023-09-14
3338451584207644K212216Prismaflex ST60 Set, Prismaflex ST100 Set, Prismaflex ST150 setKDI2022-04-01
186051584207644K212216Prismaflex ST60 Set, Prismaflex ST100 Set, Prismaflex ST150 setKDI2022-04-01
3338452040722029K201867Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the Homechoice Claria APD SystemFKX2020-11-19
3346602040722029K201867Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the Homechoice Claria APD SystemFKX2020-11-19
3338451483072827K201809AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber AccessoryKDI2021-03-10
3338451997992711K193482PrisMax System Version 3KDI2020-03-13
186091997992711K193482PrisMax System Version 3KDI2020-03-13
3338451019299460K190910PrisMax System Version 2KDI2019-07-25
186091019299460K190910PrisMax System Version 2KDI2019-07-25
3338452073643942K163530PrisMax Control UnitKDI2017-05-03
186101934156211K162887PrismaSATEKPO2017-01-06
3338451934156211K162887PrismaSATEKPO2017-01-06
3338451233522075K152675EXTENDED LIFE CAPD TRANSFER SET, PERITONEAL DIALYSIS TITANIUM CATHETER ADAPTER AND LOCKING CAP FOR TITANIUM CATHETER ADAPTERKDJ2015-10-29
3347231233522075K152675EXTENDED LIFE CAPD TRANSFER SET, PERITONEAL DIALYSIS TITANIUM CATHETER ADAPTER AND LOCKING CAP FOR TITANIUM CATHETER ADAPTERKDJ2015-10-29
3347231853369401K152129FlexiCap Disconnect Cap with Povidone-Iodine Solution, MiniCap with Povidone-Iodine SolutionKDJ2015-10-29
3338451945361280K151525Amia Automated PD System with SharesourceFKX2015-10-09
3338451848042131K133807MARS MONITOR ITC US, MARS TREATMENT KIT TYPE 1116/1 - X-MARS US, PRISMAFLEX CONTROL UNITFLD2014-03-26
186091104090762K131516PRISMAFLEX SYSTEM 7.10KDI2014-01-03
186101290984572K120333PRISMASATE DIALYSIS SOLUTIONS FOR CONTINUIUS RENAL REPLACEMENT THERAPYKPO2012-05-25
186091670555542K103832PHOENIX HEMODIALYSIS DELIVERY SYSTEMKDI2011-05-20
3338451157075144K102936HOMECHOICE/HOMECHOICE PRO AUTOMATED PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM MODEL 5C4471, 5C8310, 5C4471R AND 5C8310RFKX2011-03-30
3346601157075144K102936HOMECHOICE/HOMECHOICE PRO AUTOMATED PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM MODEL 5C4471, 5C8310, 5C4471R AND 5C8310RFKX2011-03-30
185981724695248K100364GAMBRO CARTRIDGE BLOOD SET LOW WEIGHT- LOW VOLUME, MODEL 003422-520FJK2010-11-03
186091175345314K083158EXALIS, SOFTWARE VERSION 1.15KDI2009-06-05
3338451083398355K080519PRISMAFLEX M150 SETKDI2008-06-13
185981083398355K080519PRISMAFLEX M150 SETKDI2008-06-13
186051083398355K080519PRISMAFLEX M150 SETKDI2008-06-13
186101167149329K072908PRISMASATE DIALYSIS SOLUTIONS FOR CONTINUOUS RENAL REPLACEMENT THERAPYKPO2008-02-04
3338451167149329K072908PRISMASATE DIALYSIS SOLUTIONS FOR CONTINUOUS RENAL REPLACEMENT THERAPYKPO2008-02-04
186091215196828K070643PHOENIX HEMODIALYSIS DELIVERY SYSTEM, VERSION 3.35KDI2007-11-02
185981194683297K070414GAMBRO CARTRIDGE BLOOD SETSFJK2007-10-12
186051396805867K042938GAMBRO PRISMAFLEX HF1000 AND HF1400 SETSKDI2005-01-06
185981396805867K042938GAMBRO PRISMAFLEX HF1000 AND HF1400 SETSKDI2005-01-06
3338451396805867K042938GAMBRO PRISMAFLEX HF1000 AND HF1400 SETSKDI2005-01-06
186051223316440K041005GAMBRO PRISMAFLEX AND GAMBRO PRISMAFLEX M60 & M100 SETSKDI2004-10-07
3338451223316440K041005GAMBRO PRISMAFLEX AND GAMBRO PRISMAFLEX M60 & M100 SETSKDI2004-10-07
185981223316440K041005GAMBRO PRISMAFLEX AND GAMBRO PRISMAFLEX M60 & M100 SETSKDI2004-10-07
3338451563847749K013724BICARTKPO2002-01-08
186102040831538K013448PRISMASATEKPO2002-01-15
186051646047839K003957DIACLEAR ULTRAFILTERFIP2001-11-01
3338451126104761
3347231126104761
3346601240706835
3346601263350191
3346601299330338
3346601714559805
3346601785666781
185981924636361
3346601963199346

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KDI272025-08-01
KPO82017-01-06
FKX72020-11-19
KDJ52015-10-29
FJK22010-11-03
FLD12014-03-26
FIP12001-11-01
MDP11986-05-27