BEUDAMED
    FDA Registration Active 🇩🇴 Dominican Republic

    Baxter Healthcare, S.A.

    Reg #: 9612052 · FEI: 3002806443 · Expires 2026
    View on FDA
    Products
    13
    Proprietary Names
    80
    Establishment Types
    2
    Classifications
    13

    Registration Details

    Registration Name
    Baxter Healthcare, S.A.
    Registration Number
    9612052
    FEI Number
    3002806443
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Parque Industrial ITABO, Carretera Sanchez KM 18 1/2 Buildings 48, 49, and 50
    City
    Haina San Cristobal
    Country
    DO

    Regulatory Submissions

    510(k) Number
    K925058

    Owner / Operator

    Firm Name
    BAXTER HEALTHCARE CORPORATION
    Operator Number
    1417572
    Address
    One Baxter Parkway
    City
    Deerfield
    State
    IL
    Postal Code
    60015
    Country
    US
    Correspondent
    Maha Nolasco

    US Agent

    Business Name
    BAXTER HEALTHCARE CORPORATION
    Contact Name
    Maha Nolasco
    Address
    25212 W. IL Route 120, RLT-04
    City
    Round Lake
    State
    IL
    ZIP
    60073
    Country
    US
    Email
    [email protected]
    Phone
    224 2706181

    Products

    Device Name Product Code
    Set, Administration, Intravascular FPA
    System/Device, Pharmacy Compounding NEP
    Set, Blood Transfusion BRZ
    Dialyzer, High Permeability With Or Without Sealed Dialysate System KDI
    Set, I.V. Fluid Transfer LHI
    Filter, Infusion Line FPB
    Stopcock, I.V. Set FMG
    Arthroscope HRX
    System, Irrigation, Urological LJH
    System, Peritoneal, Automatic Delivery FKX
    Administrations Sets With Neuraxial Connectors PWH
    System, Hemodialysis, Remote Accessories MON
    Container, I.V. KPE

    Proprietary Names

    Bard Epidural Spike Tubing Set Continu-Flo Clearlink Interlink Control-A-Flo I.V. Administration Set with Control-A-Flo Regulator PCA Syringe Sets MICROMIX BCR COMPOUNDER All-In-One Two Chamber Container Automix 3+3/AS Compounder System REPEATER PUMP Extension Set MICROMIX COMPOUNDER AN Abacus Luer Lock Universal Spike EM2400 Pharmacy Compounder INTELLIFILL I.V. ExactaMix Pro 2400 Display Module - Refurbished ExactaMix Pro 2400 Display Module ExactaMix Pro 1200 Display Module - Refurbished ExactaMix Pro 1200 Display Module LOGIX Transfer Set REPEATER PUMP Tube Sets AUTOMIX 3+3 COMPOUNDER Duo-Vent Solutions Administration Sets with 0.2 Micron Filter Clearlink System Solution Set Solution Sets, Extension Sets Blood Recipient Set Clearlink System PrisMax CHEMO-AIDE DISPENSING PIN Solution Set Secondary Medication Set ContinuFlo Solution Set Intravascular Administration Sets Solution Administration Sets 3 Port Adapter Solution Set for Epidural Use TUR Irrigation Set Cystoscopy Irrigation Set Arthroscopic Irrigation Set Uromatic Arthromatic Blood Administration Sets Paclitaxel Sets Interlink System Micro-Volume MICRO-VOLUME Extension Set FENWAL BLOOD RECIPIENT SET Integrated APD Set with Cassette-3 prong Interlink System T-Connector ExtSet Blood Administration Set Intravascular Extension Set (Light Resistant Extension Set) Solution Administration Set Intravascular Administration Sets with Stopcock and Manifold Radiation Sterilized Extension Sets Buretrol Mini-Infuser Stopcock and I.V. Solution Administration Sets with Stopcocks PCEA Syringe Set Buretrol Solution Sets Interlink Universal Vial Adapter Flo-Gard Colleague Low Plasticizer Administration Sets 3 Lead Ext w/2 Interlink Inject Sit Neutral Luer Activated Device (One-Link Needle-free IV Connector) and Extension Sets with One-Link Needle-free IV Connec One-Link Solution Set .22 Micron Filter Interlink System with Duo-Vent Spike Continu-Flo Solution Set Neutral Luer Activated Device (One-Link Needle-free IV Connector) and Extension Sets Clearlink System with Duo-Vent Spike Sterile Bag IntraVia Container Empty IntraVia Intravascular Extension Sets and Accessories Clearlink Luer Activated Valve

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)