FDA.reportPublic FDA data

Gambro UF Solutions LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30035046043003504604Gambro UF Solutions LLC1N2026-01-011405 Xenium Ln N, Suite 150 Plymouth MN US 55441

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1288221625554406K923065BAXTER PERSONAL CYCLER AUTOMMATED PERITONEAL DIALFKX1994-03-04
1288221323811582K791899CYCLER SETS MOD. #5C4143, 5C4144, 5C4145KDJ1979-11-13
1288221920041302K231849MiniCap Extended Life PD Transfer Set with Twist Clamp - Code 5C4482A; MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short - Code 5C4483KDJ2024-03-12
1288221506618409K21401615L Cycler Drainage BagKDJ2022-03-18
1288221997992711K193482PrisMax System Version 3KDI2020-03-13
1288221019299460K190910PrisMax System Version 2KDI2019-07-25
1288222073643942K163530PrisMax Control UnitKDI2017-05-03
1288221853369401K152129FlexiCap Disconnect Cap with Povidone-Iodine Solution, MiniCap with Povidone-Iodine SolutionKDJ2015-10-29
1288221945361280K151525Amia Automated PD System with SharesourceFKX2015-10-09
1288221157075144K102936HOMECHOICE/HOMECHOICE PRO AUTOMATED PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM MODEL 5C4471, 5C8310, 5C4471R AND 5C8310RFKX2011-03-30
1288221262518114K012988HOMECHOICE PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM, MODELS 5C8310, 5C8302, 5C4471, 5C4469FKX2001-12-05
1288221126104761
1288221181136568

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KDJ42024-03-12
FKX42015-10-09
KDI32020-03-13