BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Fresenius Medical Care Renal Therapies Group, LLC

    Reg #: 1225714 · FEI: 3001451489 · Expires 2026
    View on FDA
    Products
    13
    Proprietary Names
    65
    Establishment Types
    2
    Classifications
    13

    Registration Details

    Registration Name
    Fresenius Medical Care Renal Therapies Group, LLC
    Registration Number
    1225714
    FEI Number
    3001451489
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    920 WINTER STREET
    City
    Waltham
    State
    MA
    ZIP
    02451
    Country
    US

    Regulatory Submissions

    510(k) Number
    K173718

    Owner / Operator

    Firm Name
    Fresenius Medical Care Renal Therapies Group, LLC
    Operator Number
    9030510
    Address
    920 WINTER STREET, --
    City
    Waltham
    State
    MA
    Postal Code
    02451
    Country
    US
    Correspondent
    Rachel Lloyd

    Products

    Device Name Product Code
    System, Peritoneal, Automatic Delivery FKX
    Set, Tubing, Blood, With And Without Anti-Regurgitation Valve FJK
    Dialysate Concentrate For Hemodialysis (Liquid Or Powder) KPO
    Set, Administration, For Peritoneal Dialysis, Disposable KDJ
    Accessories, Blood Circuit, Hemodialysis KOC
    Dialyzer, High Permeability With Or Without Sealed Dialysate System KDI
    Subsystem, Water Purification FIP
    System, Dialysate Delivery, Semi-Automatic, Peritoneal KPF
    Disinfectant, Dialysate Delivery System NII
    Dialyzer, Capillary, Hollow Fiber FJI
    Autonomous Extracorporeal Blood Leak Detector/Alarm ODX
    Hemodialysis System For Home Use ONW
    Protector, Transducer, Dialysis FIB

    Proprietary Names

    Liberty Cycler Set StaySafe Handi-Tool StaySafe Organizer StaySafe Clip StaySafe Organizer Holder Fresenius BVM Hemodialysis Blood Tubing Set with Priming Set Bicarby CATHETER ADAPTER SEALING CAP NaturaLyte Liquid Acid Concentrate Citrasate Liquid Acid Concentrate Fresenius Sterile Stay Safe Cap Crit-Line Clip (CLiC) Blood Chamber 2008T BlueStar Hemodialysis Machine AquaBplus PACK-PD Peritoneal Dialysis Urea Kinetic Modeling Software Program 5008X CAREsystem Hemoflow F4 Dialyzer Hemoflow F3 Dialyzer Granuflo Dry Acid Concentrate Citrasate Dry Acid Concentrate Combilines Hemodialysis Blood Tubing Set Fresenius Priming Set with Needless Access Port Optiflux F180NR Dialyzer 4 LEAD ECO PREFILLED W/SNAP DISCONNECT 2008K@HOME HEMODIALYSIS MACHINE CombiSet - 2008 Series Home Hemodialysis with Prime Bag 2008K Hemodialysis Machine 2008T Hemodialysis Machine 2008K@home Hemodialysis Machine AquaA CombiSet Hemodialysis Blood Tubing Set 2008K@Home HD Machine w/WWD (WETALERT) AquaC UNO H CritLine IV System Fresenius Bloodlines Patient Connector (HemaClip) Fresenius Liberty Select Cycler Aqua C UNO H stay safe Drain Set Multiple Tubing Segment (MTS) Set with stay safe PIN Connectors bibag Bicarby Dialysate Fresenius Standalone Access Flow Reserving Connector NaturaLyte Dry Bicarbonate Concentrate CombiSet SMARTECH Hemodialysis Blood Tubing Sets Liberty Drain Line Fresenius Combilines Blood Tubing Set APD Luer Lock Adapter Optiflux F160NR, F180NR, F200NR, F250NR Dialyzers StaySafe to Luer-Lock Adapater StaySafe Catheter Ext Set with Luer-Lock, 12 StaySafe Catheter Ext Set with Luer-Lock, 6 StaySafe Catheter Ext Set with Safe-Lock, 12 StaySafe Catheter Ext Set with Luer-Lock, 18 5008X Hemodialysis System stay•safe Catheter Extension Sets AquaBplus, AquaB LITE Safe-Lock Universal Connector 2008K2 Hemodialysis Machine Liberty Select Cycler Granuflo Mixing System Safe-Lock catheter adapter Co-Pack II Fresenius Combilines Single Needle Blood Tubing Set Transducer Protectors Cycler Drain Bag Set NaturaLyte Dry Bicarbonate (08-4112-2)

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility