BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Baxter Healthcare of Puerto Rico LLC

    Reg #: 2649614 · FEI: 2649614 · Expires 2026
    View on FDA
    Products
    33
    Proprietary Names
    49
    Establishment Types
    2
    Classifications
    33

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    Registration Details

    Registration Name
    Baxter Healthcare of Puerto Rico LLC
    Registration Number
    2649614
    FEI Number
    2649614
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    RD. 721, KM. 0.3
    City
    AIBONITO
    State
    PR
    ZIP
    00705
    Country
    US

    Regulatory Submissions

    510(k) Number
    K060074

    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

    Products

    Device Name Product Code
    Set, Administration, Intravascular FPA
    Set, I.V. Fluid Transfer LHI
    Blade, Saw, General & Plastic Surgery, Surgical GFA
    Bur, Ear, Nose And Throat EQJ
    Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment HWE
    Instrument, Biopsy KNW
    Injector, Vertebroplasty (Does Not Contain Cement) OAR
    Cement Obturator LZN
    Gauze/Sponge, Internal, X-Ray Detectable GDY
    Fastener, Fixation, Nondegradable, Soft Tissue MBI
    Orthopedic Manual Surgical Instrument LXH
    Bone Cement LOD
    Cement, Bone, Vertebroplasty NDN
    Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece ERL
    Arthroscope HRX
    Mixer, Cement, For Clinical Use JDZ
    Bur, Surgical, General & Plastic Surgery GFF
    Laparoscope, General & Plastic Surgery GCJ
    Syringe, Piston FMF
    Bit, Drill HTW
    Spinal Channeling Instrument, Vertebroplasty OCJ
    Kit, Surgical Instrument, Disposable KDD
    Accessories, Arthroscopic NBH
    Screw, Fixation, Bone HWC
    Container, I.V. KPE
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Evacuator, Gastro-Urology KQT
    Laparoscope, Gynecologic (And Accessories) HET
    Apparatus, Suction, Operating-Room, Wall Vacuum Powered GCX
    System, Irrigation, Urological LJH
    Lavage, Jet FQH
    Transport Systems, Anaerobic JTX
    System, Transport, Aerobic JTW

    Proprietary Names

    Interlink System T Connector Ext Se Continu-Flo Interlink Interlink Universal Vial Adapter Clearlink None The Mill Disposable - Fine The Mill Disposable - Medium Duo-Vent AutoPlex w/o Needle Int. PCD, 11G Needle 100mm Femoral Nozzle High Vac. Mix Bowl Revolution Cancellous Nozzle w/Press Kit Femoral Nozzle High Vac.Mix.Bowl with Femoral Nozzle 180 gr. Cartridge With Femoral Nozzle Revolution 65 Posterior Femoral Press Nozzle Revolution CMS w/ Femoral Breakaway Nozzle Revolution Humeral Nozzle 180 gr. Cartridge Small Prox. Press (W/O Hub) PCD, W/O Needle 65 deg. Post. Fem. Press Strykeflow 2 with Tip Strykeflow Disposable S/I Tip Solution Sets w/Capless Luer Valve Control-A-Flo Buretrol OptaBlate 11G Hand Drill Pack Clearlink Luer Activated Valve Neutral Luer Activated Device (One-Link Needle-free IV Connector) and Extension Sets with One-Link Needle-free IV Connec One-Link Knotilus+ Dual Luer Lock Cap Aviva Viaflex Additive Cap StrykeFlow II with Connected Tubing Strykeflow Single Spike Tube Set StrykeFlow PS StrykeFlow II 10" Suction Irrigator Interlink System T-Connector ExtSet Ahto Cassette Tube Set with tip Ahto Dual Spike Cassette Tube Set Ahto Cassette Tube Set COPAN LIQUID AMIES ELUTION SWAB (ESWAB) COLLECTION AND TRANSPORT SYSTEM Radiation Sterilized Extension Sets Mini-Infuser

    Establishment Types

    Manufacture Medical Device Sterilize Medical Device for Another Party (Contract Sterilizer)