FDA.reportPublic FDA data

Fresenius-Medical-Care

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
12257143001451489Fresenius Medical Care Renal Therapies Group, LLC1Y2026-01-01920 WINTER STREET Waltham MA US 02451
30070845303007084530Fresenius Medical Care Seating (Australia) Pty. Ltd.1N2020-04-25786 Stud Road Scoresby Victoria AU 3179

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
00840861100774stay.safe® - stay.safe® to Luer-lock Adapter, 4 inch+1(800)323-5188xxx@xxx.xxx
00840861101955NaturaLyte - NaturaLyte Dry Pack Sodium Bicarbonate RX 12 bag; NaturaLyte Dry Bicarbonate Concentrate (08-4112-2)+1(800)323-5188xxx@xxx.xxx
04039361261313DIASAFE®plusUS - F000130101-800-323-5188Customer.service@fmc-na.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
171261532449650K994267FRESENIUS 2008KKDI2000-03-16
171261527473225K981043DIALYSOL-ACID CONCENTRATE LIQUID, GRANUSOL-ACID CONCENTRATE POWDER, RENALSOL-ACETATE CONCENTRATE LIQUID & POWDER, BIOSOLKPO1998-05-26
171261300616115K980659DRYALYSATE CONCENTRATEKPO1998-06-11
171261009644882K962081COMBILINES HEMODIALYSIS BLOOD TUBING SETFJK1996-11-01
171261112799723K955762PACKPD PERITONEAL DIALYSIS UREA KINETIC MODELING SOFTWARE PROGRAMKPF1996-07-31
171262054002157K944767DIALYSIS MACHINE WITH DIALYSATE ULTRAFILTERFIP1995-11-29
171262021603213K935958CRIT-LINE BLOOD CHAMBER WITH E-BEAMKOC1995-01-19
171261962566312K921134FRESENIUS POLYSULFONE DIALYZERSKDI1993-12-02
171261443188506K915628DEXTROLYTE II PERITONEAL DIALYSIS PUMPKDJ1992-03-16
171261270972265K911459GRANULYTE POWDER DIALYSATE CONCENTRATE AND MIXINGKPO1991-07-17
171262036418303K904806CAPD SAFELOCK TRANSFER SET W/PRE-FILLED CONNECTORKDJ1991-01-11
171262037481116K896764UNIVERSAL CONNECTOR CATALOG NO. 48-1025-5KDJ1990-02-26
171261591516136K870725FRESENIUS HEMOFLOW F6 AND F8FJI1987-05-01
171261200009019K822550SAFE LOCK TITANIUM ADAPTER SETFKX1982-10-13
171261224114006K822546SAFE LOCK SEALING CAPSFKX1982-10-13
171261579141212K811986THE AMP 80/2 PEDIATRIC CYCLER SYSTEMFKX1981-08-31
171261673334042K253462NaturaLyte® Dry Bicarbonate Concentrate (08-4112-2)KPO2026-01-29
171261647087274K252181AquaAFIP2025-09-09
171261018000443K252180Bicarby Dialysate RFP-404 (RFP-404-W); Bicarby Dialysate RFP-403 (RFP-403-W); Bicarby Dialysate RFP-403 (RFP-403-G); Bicarby Dialysate RFP-453 (RFP-453-W); Bicarby Dialysate RFP-453 (RFP-453-G); Bicarby Dialysate RFP-454 (RFP-454-W); Bicarby Dialysate RFP-454 (RFP-454-G); Bicarby Dialysate RFP-456 (RFP-456-W)KPO2025-09-09
171261384509466K250471AquaC UNO HFIP2025-11-14
171261534126491K250404stay•safe® catheter extension set with Safe- Lock, 12 inch; stay•safe® catheter extension set with Luer-Lock, 6 inch; stay•safe® catheter extension set with Luer-Lock, 12 inch; stay•safe® catheter extension set with Luer-Lock, 18 inch; stay•safe® to Luer-Lock Adapter, 4 inchKDJ2025-04-03
171261386783212K243786Bicarby Dialysate RFP-402 (RFP-402-G); Bicarby Dialysate RFP-400 (RFP-400-G); Bicarby Dialysate RFP-407 (RFP-407-G); Bicarby Dialysate RFP-401 (RFP-401-G); Bicarby Dialysate RFP-404 (RFP-404-G); Bicarby Dialysate RFP-456 (RFP-456-G); Ci-Ca Dialysate 2K (RFP-457-G); Ci-Ca Dialysate 4K (RFP-458-G)KPO2025-04-04
171261715745078K2435055008X Hemodialysis SystemKDI2025-05-30
171261214018675K2432372008T HD SYS. CDX BLUESTAR (191124); 2008T HD SYS. CDX W/bibag BLUESTAR (191126); 2008T HD SYS. W/O CDX BLUESTAR (191128); 2008T HD SYS. W/O CDX W/bibag BLUESTAR (191130)KDI2025-06-13
171261313277838K233950pureFLOW 402 (F00012067); pureFLOW 406 (F00012068); pureFLOW 401 (F00012069); pureFLOW 400 (F00012070)KPO2024-05-10
171261508555187K232953AquaBplus; AquaB LITEFIP2024-06-13
171261114709229K2315345008X Hemodialysis SystemKDI2024-02-02
171261531732913K2311252008T BlueStar Hemodialysis MachineKDI2023-12-06
171261370941560K2229522008T BlueStar Hemodailysis MachineKDI2022-10-27
171261407461172K222318Fresenius Liberty Select CyclerFKX2022-10-31
171261413774632K213992CombiSet Hemodialysis Blood Tubing SetFJK2023-05-31
171261267419319K213507AquaAFIP2022-07-27
171261625657054K212620Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid ConcentrateKPO2022-05-12
171261726989893K201207CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Integrated Crit-Line Technology, CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Intergrated Crit-Line Technology, no Heparin LineKOC2020-09-18
171261458191945K192707Optiflux F180NR DialyzerKDI2020-09-21
171261681571498K192209Citrasate Dry Acid Concentrate, Granuflo Dry Acid ConcentrateKPO2020-05-08
171261107381683K192017Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid ConcentrateKPO2020-04-24
171261082713033K191474NaturaLyte Dry Bicarbonate Concentrate (Rx-10 Bag), NaturaLyte Dry Bicarbonate Concentrate (Rx-12 Bag), NaturaLyte Dry Bicarbonate Concentrate (Carton)KPO2020-02-24
171261473419817K190459Hemoflow F3 and F4 DialyzersFJI2019-08-23
171261594909286K182367DIASAFEplusUSFIP2019-01-10
171261831260214K181108Fresenius Liberty Select CyclerFKX2018-05-24
171261187328696K1739722008T BlueStar Hemodialysis MachineKDI2018-05-10
171261567630452K173718Liberty Cycler SetFKX2018-05-01
171261957102242K173651Multiple Tubing Segment Set with stay safe PIN Connectors, stay safe Drain SetKDJ2018-02-14
171261055070394K173593stay•safe catheter extension set with Safe-Lock, 12 inch, stay•safe catheter extension set with Luer-Lock, 6 inch, stay•safe catheter extension set with Luer-Lock, 12 inch, stay•safe catheter extension set with Luer-Lock, 18 inch, stay•safe to Luer-Lock adapter, 4 inchKDJ2018-05-21
171261440169474K173363Cycler Drain Bag SetKDJ2018-01-24
171261695900215K172238CAREline Airless Hemodialysis Blood Tubing SetsKOC2017-12-14
171261071355928K171652Fresenius Liberty Select CyclerFKX2017-09-15
171261880094701K162716bibagKPO2017-05-18
171261022678672K162488Optiflux dialyzerKDI2017-04-06
171261247313201K160749CRIT-LINE III Blood Chamber IIKOC2016-04-15
171261858750875K1534492008K2 Hemodialysis MachineKDI2016-04-26
171261502160313K152953CRIT-LINE CLIP (CLIC) BLOOD CHAMBERKOC2015-11-05
171261368862327K1507082008K Hemodialysis Machine, 2008K@home Hemodialysis Machine, 2008T Hemodialysis MachineKDI2015-12-10
171261351527309K143617AquaC UNO HFIP2015-10-19
171261411997792K141997CRIT-LINE IV SYSTEMKOC2015-04-01
171261832003599K141145LIBERTY PDX CYCLERFKX2014-07-30
171261473110099K133829AQUABPLUS,AQUABPLUS & AQUABPLUS B2,AQUABPLUS&AQUABPLUS HF,AQUABPLUS& AQUABPLUS B2& AQUABLUS HFFIP2014-04-22
171261068960956K133299ACETIC ACID WAND, ACID WAND ASSEMBLY, BICARBONATE WAND ASSEMBLYKDI2014-07-07
171261970426534K131611FRESENIUS DRY ACID DISSOLUTION UNITSKPO2013-08-29
171261781972934K1240352008K@HOME HEMODIALYSIS MACHINEONW2013-07-03
171262026515121K124024APD LUER-LOCK ADAPTERKDJ2013-09-19
171261841707119K123630FRESENIUS LIBERTY CYCLERFKX2013-09-09
171261286801815K121599CRIT-LINE CLIP (CLIC)KOC2012-11-09
171261055599414K121421FRESENIUS 2008K HOME HEMODIALYSIS MACHINE WITH WIRELESS WETNESS DETECTOR (WETALERT)ONW2013-01-17
171261746372367K120823BVM HEMODIALYSIS BLOOD TUBING SET WITH ATTACHED PRIMING SET AND TRANSDUCER PROTECTORSFJK2012-06-15
895051448515578K112944FRESENIUS MEDICAL TREATMENT CHAIR T688 SERIESINO2011-12-30
895051576888363K091727MEDICAL TREATMENT CHAIR, T400, T500,T600INO2009-07-06
171261510810106K083542FRESENIUS STERILE STAY SAFE CAPKDJ2008-12-29
171261629522469K070177FRESENIUS NATURALYTE LIQUID ACID CONCENTRATE, 9000, 6000 AND 4000 SERIESKPO2007-03-29
171261683716697K070049FRESENIUS 2008K @HOME WITH WIRELESS WETNESS DETECTORONW2011-02-03
171261528941497K043363FRESENIUS LIBERTY CYCLERFKX2005-03-31
171261221974634K043244FRESENIUS OPTIFLUX F20NR, FF18NR, F16NRKDI2004-12-20
171261402351667K041042SPLIT SEPTUM INJECTION SITESFPA2004-07-16
171262064210324K030497FRESENIUS NATURALYTE GRANUFLO DRY ACID CONCENTRATE 10XX SERIES, 24XX SERIES, 30XX SERIESKPO2003-05-20
171261486357218K022536\RESENIUS ACCESS FLOW RESERVING CONNECTORS, FRESENIUS STANDALONE ACCCES FLOW RESERVING CONNECTORKOC2002-10-30
171261161009327K022412FRESENIUS CAPD STAY.SAFE DISPOSABLE ADMINISTRATION SETS WITH STAY.SAFE CONNECTORKDJ2003-03-05
171261898084617K011741CRIT-LINE MONITOR III TQA (CLM TQA)FIL2002-07-23
171261417225464K010268FRESENIUS PRIMING SET WITH NEEDLES ACCESS PORT, MODEL 04-9002-9KOC2001-04-27
171261309175448K003445FRESENIUS VIRAL BLOCKING TRANSDUCER PROTECTOR FOR HEMODIALYSIS, MODEL 04-9500-2FIB2000-12-01
171261461704573K002892FRSENIUS PD IQCARD CYCLERFKX2001-04-05
171261455131653K002277FRESENIUS OPTIFLUX 200NRKDI2000-08-25
171261597627448K001873HEMOSAFE PATIENT CONNECTOR FOR FRESENIUS BLOODLINES, MODEL 04-9100-0FJK2000-07-28
171261948775068K001107FRESENIUS COMBILINES LOW VOLUME BLOOD TUBING SET, MODELS 03-2291 (POST PUMP) AND 03-2292 (PRE-PUMP)FJK2000-06-23
171261251242227K000792CITRASATE DIALYSATE ACID CONCENTRATE LIQUID, MODELS CS-1XXX-XX, CS-XXX-XX, CS-3XXX-XXKPO2000-06-08
171261620433036K000451FRESENIUS COMBILLINES SINGLE NEEDLE BLOOD TUBING SET, CATALOG #03-2290FJK2000-05-09
895051464441982
171261802376684
895051954510524

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KPO172026-01-29
KDI152025-06-13
FKX112022-10-31
KDJ102025-04-03
KOC92020-09-18
FIP82025-11-14
FJK62023-05-31
ONW32013-07-03
FJI22019-08-23
INO22011-12-30
FPA12004-07-16
FIL12002-07-23
FIB12000-12-01
KPF11996-07-31

NDC#

Delflex

Fresenius Medical Care de Mexico, S.A. de C.V.

dextrose monohydrate, sodium chloride, sodium lactate, calcium chloride, magnesium chloride

Delflex

Fresenius Medical Care de Mexico, S.A. de C.V.

dextrose monohydrate, sodium chloride, sodium lactate, calcium chloride, magnesium chloride

Delflex

Fresenius Medical Care de Mexico, S.A. de C.V.

dextrose monohydrate, sodium chloride, sodium lactate, calcium chloride, magnesium chloride

Sodium Chloride

Fresenius Medical Care de Mexico, S.A. de C.V.

Sodium Chloride

DELFLEX

Fresenius Medical Care North America

Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride

DELFLEX

Fresenius Medical Care North America

Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride

DELFLEX

Fresenius Medical Care Renal Therapies Group, LLC

Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride

DELFLEX

Fresenius Medical Care Renal Therapies Group, LLC

Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride

DELFLEX

Fresenius Medical Care Renal Therapies Group, LLC

Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride

DELFLEX

Fresenius Medical Care Renal Therapies Group, LLC

Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride

DELFLEX

Fresenius Medical Care Renal Therapies Group, LLC

Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride

DELFLEX

Fresenius Medical Care Renal Therapies Group, LLC

Dextrose Monohydrate, Sodium Chloride, Sodium Lactate, Calcium Chloride, Magnesium Chloride

Sodium Chloride

Fresenius Medical Care Renal Therapies Group, LLC

Sodium Chloride

Venofer

Fresenius Medical Care Holdings, Inc.

iron sucrose

Venofer

Fresenius Medical Care Holdings, Inc.

iron sucrose

Velphoro

Fresenius Medical Care Renal Therapies Group, LLC

sucroferric oxyhydroxide

PMN#

AquaA

2022-07-27

Fresenius Medical Care Rental Therapies Group, LLC

DIASAFEplusUS

2019-01-10

Fresenius Medical Care Renal Therapies Group, LLC

Bibag

2017-05-18

FRESENIUS MEDICAL CARE RENAL THERAPIES GROUP, LLC

101 records. Showing 1-40. Next

GUDID#

80 records. Showing 1-40. Next