FDA.reportPublic FDA data

Vantive US Healthcare LLC

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
23149122314912Vantive US Healthcare LLC1N2026-01-011900 NORTH HIGHWAY 201 MOUNTAIN HOME AR US 72653
30303060553030306055Vantive US Healthcare LLC1Y2026-01-01One Baxter Parkway Building 6 Deerfield IL US 60015
30381950113038195011Vantive US Healthcare LLC1Y2026-01-01510 Lake Cook Rd Deerfield IL US 60015
30426396093042639609Vantive US Healthcare LLC1Y2026-01-018640 Nail Rd Ste 110 Olive Branch MS US 38654

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
07332414207946LOCKING TITANIUM ADAPTER FOR PERITONEAL DIALYSIS CATHETER - This adapter is a double sealing female Luer lock adapter with a 2-piece, combination compression fit/barbed catheter connector. The adapter is used to connect the PD catheter to a solution transfer set with locking connector.+1(800)553-6898osr.largo@vantive.com
07332414208011FLEXICAP DISCONNECT CAP WITH POVIDONE-IODINE SOLUTION - This device is a plastic disconnect cap for Automated Peritoneal Dialysis (APD) containing povidone-iodine.+1(800)284-4060US.customerservice@vantive.com
07332414208264Minicap - This device is a plastic disconnect cap for peritoneal dialysis and contains povidone-iodine intended to protect the female Luer connector of the Baxter transfer set.+1(800)284-4060US.customerservice@vantive.com
07332414208479HOMECHOICE APD SET - HOMECHOICE APD SET WITH CASSETTE AND 4 PRONG SPIKE+1(888)736-2543uscanmedinfo@vantive.com
27332414207940LOCKING TITANIUM ADAPTER FOR PERITONEAL DIALYSIS CATHETER - This adapter is a double sealing female Luer lock adapter with a 2-piece, combination compression fit/barbed catheter connector. The adapter is used to connect the PD catheter to a solution transfer set with locking connector.+1(800)553-6898osr.largo@vantive.com
57332414208016FLEXICAP DISCONNECT CAP WITH POVIDONE-IODINE SOLUTION - This device is a plastic disconnect cap for Automated Peritoneal Dialysis (APD) containing povidone-iodine.+1(800)284-4060US.customerservice@vantive.com
57332414208269Minicap - This device is a plastic disconnect cap for peritoneal dialysis and contains povidone-iodine intended to protect the female Luer connector of the Baxter transfer set.+1(800)284-4060US.customerservice@vantive.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3407341023383322P830063GAMBRO FIBER PLASMAFILTERMDP1986-05-27
3407341655387667K961825ULTRASET/3L CAPD DISPOSABLE DISCONNECT Y-SET MODELS 5C4366 & 5C4493KDJ1996-08-06
3326781655387667K961825ULTRASET/3L CAPD DISPOSABLE DISCONNECT Y-SET MODELS 5C4366 & 5C4493KDJ1996-08-06
3326781338082567K925403BAXTER APD 12' EXTENSION LINEKDJ1994-02-22
3407341338082567K925403BAXTER APD 12' EXTENSION LINEKDJ1994-02-22
3407341625554406K923065BAXTER PERSONAL CYCLER AUTOMMATED PERITONEAL DIALFKX1994-03-04
3326781625554406K923065BAXTER PERSONAL CYCLER AUTOMMATED PERITONEAL DIALFKX1994-03-04
3407341953521502K833065AUTOMATIC PERITONEAL DIALYSIS CYCLERFKX1983-11-28
3326781953521502K833065AUTOMATIC PERITONEAL DIALYSIS CYCLERFKX1983-11-28
3407341277847247K823707HOSPAL BLOOD LINESKOC1983-01-05
3407341666528518K801016GAMBRO G SERIES BLOOD LINE SETS FOR HEM.FJK1980-05-30
3407341323811582K791899CYCLER SETS MOD. #5C4143, 5C4144, 5C4145KDJ1979-11-13
3326781323811582K791899CYCLER SETS MOD. #5C4143, 5C4144, 5C4145KDJ1979-11-13
3407341489274396K250508AK 98 Dialysis Machine (955607)KDI2025-08-01
3407341418252250K232467CleanCart A, CleanCart C, AK 98 Hemodialysis MachineKDI2023-09-14
3407341920041302K231849MiniCap 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
3326781920041302K231849MiniCap 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
3407341506618409K21401615L Cycler Drainage BagKDJ2022-03-18
3326781506618409K21401615L Cycler Drainage BagKDJ2022-03-18
3407341673036134K213639Revaclear 500, Revaclear 400, Revaclear 300KDI2022-01-24
3407341445837300K211035U9000 Plus UltrafilterFIP2021-10-19
3239032040722029K201867Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the Homechoice Claria APD SystemFKX2020-11-19
3407342040722029K201867Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the Homechoice Claria APD SystemFKX2020-11-19
3407341483072827K201809AK 98 Dialysis Machine, U9000 Ultrafilter, C705 Expansion Chamber AccessoryKDI2021-03-10
3407341997992711K193482PrisMax System Version 3KDI2020-03-13
3407341019299460K190910PrisMax System Version 2KDI2019-07-25
3407342073643942K163530PrisMax Control UnitKDI2017-05-03
3407341934156211K162887PrismaSATEKPO2017-01-06
3407341233522075K152675EXTENDED LIFE CAPD TRANSFER SET, PERITONEAL DIALYSIS TITANIUM CATHETER ADAPTER AND LOCKING CAP FOR TITANIUM CATHETER ADAPTERKDJ2015-10-29
3326781233522075K152675EXTENDED LIFE CAPD TRANSFER SET, PERITONEAL DIALYSIS TITANIUM CATHETER ADAPTER AND LOCKING CAP FOR TITANIUM CATHETER ADAPTERKDJ2015-10-29
3407341853369401K152129FlexiCap Disconnect Cap with Povidone-Iodine Solution, MiniCap with Povidone-Iodine SolutionKDJ2015-10-29
3239031945361280K151525Amia Automated PD System with SharesourceFKX2015-10-09
3326781945361280K151525Amia Automated PD System with SharesourceFKX2015-10-09
3407341945361280K151525Amia Automated PD System with SharesourceFKX2015-10-09
3407341848042131K133807MARS MONITOR ITC US, MARS TREATMENT KIT TYPE 1116/1 - X-MARS US, PRISMAFLEX CONTROL UNITFLD2014-03-26
3407341142140372K130039REVACLEAR 300 DIALYZER, REVACLEAR 400 DIALYZERKDI2013-05-02
3407341301746045K113313MOLECULAR ADSORBENT RECIRCULATING(MARS)FLD2012-12-14
3407341157075144K102936HOMECHOICE/HOMECHOICE PRO AUTOMATED PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM MODEL 5C4471, 5C8310, 5C4471R AND 5C8310RFKX2011-03-30
3326781157075144K102936HOMECHOICE/HOMECHOICE PRO AUTOMATED PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM MODEL 5C4471, 5C8310, 5C4471R AND 5C8310RFKX2011-03-30
3407341724695248K100364GAMBRO CARTRIDGE BLOOD SET LOW WEIGHT- LOW VOLUME, MODEL 003422-520FJK2010-11-03
3407341083398355K080519PRISMAFLEX M150 SETKDI2008-06-13
3407341167149329K072908PRISMASATE DIALYSIS SOLUTIONS FOR CONTINUOUS RENAL REPLACEMENT THERAPYKPO2008-02-04
3407341194683297K070414GAMBRO CARTRIDGE BLOOD SETSFJK2007-10-12
3407341032695987K051520GAMBRO POLYFLUX HEMODIALYZER, MODEL 6HKDI2005-12-09
3407342071852981K043342POLYFLUX FAMILY HEMODIALYZER/FILTER LABELED FOR SINGLE AND MULTIPLE USE, MODELS 14L, 17L, 21L, 140H, 170H, 210H,6LR, 8LRFJI2005-05-27
3407341396805867K042938GAMBRO PRISMAFLEX HF1000 AND HF1400 SETSKDI2005-01-06
3407341223316440K041005GAMBRO PRISMAFLEX AND GAMBRO PRISMAFLEX M60 & M100 SETSKDI2004-10-07
3407341563847749K013724BICARTKPO2002-01-08
3326781262518114K012988HOMECHOICE PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM, MODELS 5C8310, 5C8302, 5C4471, 5C4469FKX2001-12-05
3407341262518114K012988HOMECHOICE PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM, MODELS 5C8310, 5C8302, 5C4471, 5C4469FKX2001-12-05
3407341646047839K003957DIACLEAR ULTRAFILTERFIP2001-11-01
3407341619075872DEN190042Theranova Dialyzers, Theranova 400 Dialyzer, Theranova 500 DialyzerQAX2020-08-28
3407341126104761
3326781126104761
3407341181136568
3407341590359294

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KDJ142024-03-12
FKX132020-11-19
KDI122025-08-01
KPO32017-01-06
FJK32010-11-03
FIP22021-10-19
FLD22014-03-26
QAX12020-08-28
FJI12005-05-27
MDP11986-05-27
KOC11983-01-05

NDC#

DIANEAL PD-2 with Dextrose

Vantive US Healthcare LLC

sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose

DIANEAL PD-2 with Dextrose

Vantive US Healthcare LLC

sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose

DIANEAL PD-2 with Dextrose

Vantive US Healthcare LLC

sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose

DIANEAL PD-2 with Dextrose

Vantive US Healthcare LLC

sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose

DIANEAL PD-2 with Dextrose

Vantive US Healthcare LLC

sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose

DIANEAL PD-2 with Dextrose

Vantive US Healthcare LLC

sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose

EXTRANEAL

Vantive US Healthcare LLC

icodextrin, sodium chloride, sodium lactate, calcium chloride, magnesium chloride

EXTRANEAL

Vantive US Healthcare LLC

icodextrin, sodium chloride, sodium lactate, calcium chloride, magnesium chloride

EXTRANEAL

Vantive US Healthcare LLC

icodextrin, sodium chloride, sodium lactate, calcium chloride, magnesium chloride

DIANEAL PD-2 WITH DEXTROSE

Vantive US Healthcare LLC

sodium chloride, sodium lactate, calcium chloride, magnesium chloride and dextrose

EXTRANEAL

Vantive US Healthcare LLC

icodextrin, sodium chloride, sodium lactate, calcium chloride, magnesium chloride

EXTRANEAL

Vantive US Healthcare LLC

icodextrin, sodium chloride, sodium lactate, calcium chloride, magnesium chloride

EXTRANEAL

Vantive US Healthcare LLC

icodextrin, sodium chloride, sodium lactate, calcium chloride, magnesium chloride

PRISMASOL

Vantive US Healthcare LLC

magnesium chloride, dextrose anhydrous, lactic acid, sodium chloride, sodium bicarbonate, and potassium chloride

48 records. Showing 1-40. Next

GUDID#