BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Vantive US Healthcare LLC

    Reg #: 3038195011 · FEI: 3038195011 · Expires 2026
    View on FDA
    Products
    15
    Proprietary Names
    65
    Establishment Types
    1
    Classifications
    15

    Registration Details

    Registration Name
    Vantive US Healthcare LLC
    Registration Number
    3038195011
    FEI Number
    3038195011
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    510 Lake Cook Rd
    City
    Deerfield
    State
    IL
    ZIP
    60015
    Country
    US

    Regulatory Submissions

    510(k) Number
    K833065
    PMA Number
    P830063

    Owner / Operator

    Firm Name
    Vantive US Healthcare LLC
    Operator Number
    9038727
    Address
    510 Lake Cook Road
    City
    Deerfield
    State
    IL
    Postal Code
    60015
    Country
    US
    Correspondent
    Jennifer Masek-Little

    Products

    Device Name Product Code
    Dressing, Wound, Hydrophilic NAC
    System, Peritoneal, Automatic Delivery FKX
    Set, Administration, For Peritoneal Dialysis, Disposable KDJ
    Dialyzer, High Permeability With Or Without Sealed Dialysate System KDI
    Dialysate Concentrate For Hemodialysis (Liquid Or Powder) KPO
    Subsystem, Water Purification FIP
    Apparatus, Hemoperfusion, Sorbent FLD
    Hemodialyzer, Re-Use, High Flux MSF
    Dialyzer, Capillary, Hollow Fiber FJI
    Clamp, Line FKK
    Set, Tubing, Blood, With And Without Anti-Regurgitation Valve FJK
    Accessories, Blood Circuit, Hemodialysis KOC
    Hemodialyzer With Expanded Solute Removal Profile QAX
    Separator For Therapeutic Purposes, Membrane Automated Blood Cell/Plasma MDP
    System, Hemodialysis, Remote Accessories MON

    Proprietary Names

    Tipstop 12 ft Extension Set Empty Sterile Container 15L Cycler Drainage Bag PrisMax System Version 3 PRISMASATE Homechoice Integrated APD Set with Cassette 3-prong Automated PD Set with Cassette 4-Prong Low Recirculation Volume APD Set with Cassette HomeChoice PRO Automated Personal Cycler U9000 Plus Ultrafilter PRISMAFLEX HF 1000 SET PRISMAFLEX HF 1400 SET PrismaSATE dialysis solutions DIACLEAR MARS Monitor ITC US, MARS Treatment Kit Type 1116/1 - X-MARS US, Prismaflex Control Unit AK 98 Dialysis Machine POLYFLUX 140H, 170H, 210H POLYFLUX 14L, 17L, 21L PrisMax System Version 2 TherMax Short Nose Clamp for Outlet Port of Plastic Container UltraClamp Tubing Clamp Ultra Set CAPD Disposable Y-Set 3L Ultra Set CAPD Disposable Y-Set Revaclear PRISMAFLEX M150 SET Gambro Bloodlines Hospal Bloodlines Cycler Sets for Peritoneal Dialysis CARTRIDGE BLOOD SET Theranova Dialyzers (Theranova 400, Theranova 500) MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short MiniCap Extended Life PD Transfer Set with Twist Clamp CleanCart A, CleanCart C, AK 98 Dialysis Machine PrisMax Homechoice Claria APD System, Sharesource Connectivity Platform for Use with the Homechoice Claria APD System POLYFLUX HEMODIALYZER MODEL 6H MiniCap with Povidone-Iodine Solution PRISMAFLEX TPE 2000 SET PRISMA TPE 2000 SET Minicap Extended Life PD Transfer Sets Locking Titanium Adapter for Peritoneal Dialysis Catheter and Locking Cap for Peritoneal Dialysis Catheter Adapter Revaclear 300 Revaclear 500 Revaclear 400 Prismaflex ST set (ST60/ST100/ST150 sets) Sterile Bag PRISMAFLEX MONITOR PRISMAFLEX M60 SET PRISMAFLEX M100 SET HomeChoice Personal Cycler Dialysis HomeChoice Low Recirculation Volume APD Set BICART Amia Automated PD System with Sharesource Cycler Set U9000 Ultrafilter C-705 Accessory Expansion Chamber Molecular Adsorbent Recirculating System (MARS) Effluent Sample Bag Automated Dialysis Cycler System Homechoice APD Set with Cassette 4 prong spike GAMBRO CARTRIDGE BLOOD SETS Baxter 12' Extension Line

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198