BEUDAMED
    FDA Registration Active 🇩🇴 Dominican Republic

    FENWAL INTERNATIONAL, INC.

    Reg #: 9612051 · FEI: 3002806457 · Expires 2026
    View on FDA
    Products
    21
    Proprietary Names
    118
    Establishment Types
    2
    Classifications
    21

    Registration Details

    Registration Name
    FENWAL INTERNATIONAL, INC.
    Registration Number
    9612051
    FEI Number
    3002806457
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    CARRETERA SANCHEZ KM 18.5, PARQUE INDUSTRIAL ITABO ZONA FRANCA Ind. De S.C.
    City
    HAINA San Cristobal
    Country
    DO

    Regulatory Submissions

    510(k) Number
    K213089
    PMA Number
    BP850001

    Owner / Operator

    Firm Name
    Fresenius Kabi AG
    Operator Number
    9027285
    Address
    Else-Kroner-Str. 1
    City
    61352 Bad Homburg
    State
    DE-NOTA
    Postal Code
    NONE
    Country
    DE

    Products

    Device Name Product Code
    Set, Administration, Intravascular FPA
    Microfilter, Blood Transfusion CAK
    Bone Marrow Collection/Transfusion Kit LWE
    Separator, Automated, Blood Cell, Diagnostic GKT
    Container, Empty, For Collection & Processing Of Blood & Blood Components KSR
    Supplies, Blood-Bank KSS
    Separator, Automated, Blood Cell And Plasma, Therapeutic LKN
    Set, Blood Transfusion BRZ
    Catheter, Continuous Flush KRA
    Sheet, Burn FPY
    Gauze / Sponge,Nonresorbable For External Use NAB
    Apparatus, Autotransfusion CAC
    Set, Transfer (Blood/Plasma) KSB
    Pump, Infusion FRN
    Infusion Safety Management Software PHC
    Bandage, Elastic FQM
    Reservoir, Blood, Cardiopulmonary Bypass DTN
    Splint, Intranasal Septal LYA
    Hemostatic Wound Dressing Without Thrombin Or Other Biologics QSY
    Transducer, Pressure, Catheter Tip DXO
    Gauze/Sponge, Internal, X-Ray Detectable GDY

    Proprietary Names

    Ivenix Infusion System (IIS) SEPACELL LEUKOCYTE REDUCTION ADMINISTRATION SETS Bone Marrow Collection Kit Bone Marrow Collection Container Bone Marrow Collection Stand AUTOPHERESIS-C INSTRUMENT, MODEL A-200 PLASMAPHERESIS INSTRUMENT Plasmacell-C Disposable Set Plasmalink Bottle with Locking Luer Adapter Slide Clamp Plasma Extractor AMICUS SEPARATOR SYSTEM AMICUS APHERESIS KITS AMICUS APHERESIS KIT-DOUBLE NEEDLE AMICUS APHERESIS KIT-SINGLE NEEDLE AMICUS APHERESIS KIT-DOUBLE NEEDLE W/PAS CONNECTOR AMICUS APHERESIS KIT - SINGLE NEEDLE AMICUS SEPARATOR (4R4580, 4R4580R) AMICUS MNC APHERESIS KIT-DOUBLE NEEDLE AMICUS APHERESIS KIT - DOUBLE NEEDLE W/PAS CONNECTOR AMICUS APHERESIS KIT-SINGLE NEEDLE W/PAS CONNECTOR AMICUS APHERESIS KIT - SINGLE NEEDLE W/PAS CONNECTOR AMICUS MNC APHERESIS KIT - DOUBLE NEEDLE AMICUS Exchange Kit - Therapeutics Waste Transfer Set AMICUS Separator System Blood Component Filter Set with Vented Spike and Luer Adapter Bone Marrow Collection Kit with Flexible Pre-Filter and Inline Filters Blood Component Transfusion Set Sampling Site Coupler With Needle ALYX COMPONENT COLLECTION SYSTEM VAMP 400 VAMP 600 VAMP 700 Y-TYPE BLOOD COMPONENT RECIPIENT SET Blood Component Recipient Set Blood Component Infusion Set SEPACELL LEUKOCYTE REDUCTION FILTER FOR RED CELLS SEPACELL R-500II LEUKOCYTE REDUCTION ADMINISTRATION SET FOR RED CELL TRANSFUSION Burn Sheet NAR Z-FOLD GAUZE NAR COMPRESSED GAUZE NAR S-ROLLED GAUZE PLASMACELL-C DISPOSABLE SET AURORA PLASMAPHERESIS SYSTEM CATSmart, Automated Blood Processing Autotransfusion System ALYX COMPONENT COLLECTION SYSTEM (4R5707, 4R5725) ALYX COMPONENT COLLECTION SYSTEM (6R5725) PLASMA TRANSFER SET Y-Type Connector Set Adaptive Nomogram Transfer Pack PLASMACELL Xi Disposable Set Aurora Xi Plasmapheresis System Plasmalink Transfer Pack Container – 2000 mL BONE MARROW COLLECTION KIT BONE MARROW COLLECTION STAND PRODUCT SAMPLE PACK AUTO-C SYSTEM AUTOPHERESIS-C PLASMAPHERESIS SYSTEM AUTOPHERESIS-C SYSTEM PSQ PLASMA SEQUESTRATION SET ATY-Y ADAPTER ATO OXYGENATOR LINE ATS SUCTION LINE HEMATYPE SEGMENT DEVICE Amicus Apheresis Kit Double Needle Closed Kit Amicus Apheresis Kit Single Needle Functionally Closed Kit Amicus Apheresis Kit Double Needle MNC Kit Amicus Apheresis Kit Double Needle Closed Kit with Platelet Additive Solution (PAS) Connector Amicus Apheresis Kit Single Needle Advanced Kit Platelet Storage Container Amicus Apheresis Kit Double Needle Advanced Kit Amicus Apheresis Kit Single Needle Closed Kit with Platelet Additive Solution (PAS) Connector Amicus Apheresis Kit Double Needle Functionally Closed Kit Amicus Apheresis Kit Single Needle Closed Kit NAR EMERGENCY TRAUMA DRESSING (ETD) 4" NAR EMERGENCY TRAUMA DRESSING (ETD) 4" FLAT NAR EMERGENCY TRAUMA DRESSING (ETD) 6" FLAT NAR EMERGENCY TRAUMA DRESSING (ETD) ABD NAR EMERGENCY TRAUMA DRESSING (ETD) 6" PLASMALINK POOLING BOTTLE Adaptive Nomogram Bottle ATR40 FRESENIUS CATS AUT ATR Cap Set ATR120 SEPACELL PRE-STORAGE LEUKOCYTE REDUCTION SETS FOR RED CELLS AMICUS Apheresis Kit - Double Needle with Inlet Line Sampling Amicus Apheresis Kit - Single Needle AMICUS Apheresis Kit - Double Needle with Platelet Additive Solution Connector AMICUS Apheresis Kit - Single Needle with Platelet Additive Solution Connector AMICUS SEPARATOR Fenwal Plasmalink Transfer Pack Container with Luer Adapter and No Outlet Ports AMICUS SEPARATOR, COLLECTION OF THREE PLATELET PRODUCTS PLASTIC STORAGE CONTAINER Fenwal Bone Marrow Collection Kit with Accessories BONE MARROW COLLECTION KIT W/ACCESSORIES BONE MARROW COLLECTION KIT WITH ACCESSORIES Bone Marrow Collection Kit and Stand LEUKOCONNECT PRE-STORAGE STERILE CONNECT LEUKOREDUCTION SET W/SEPACELL FILTER FOR RED BLOOD CELLS DISPOSABLE APHERESIS KIT Red Blood Cell Freezing Pack Transfer-Pack ALYX 2RBC-LR Kit ALYX 2RBC DISPOSABLE SET ALYX Component Collection System ALYX INSTRUMENT AMICUS SEPARATOR, MONONUCLEAR CELL COLLECTION AMICUS EXCHANGE KIT HEMOPAD PLUS V-PAD T-PAD Amicus Apheresis Kit – Functionally Closed Single Needle with PAS Spike and Dual Plasma Containers AMICUS Separator AMICUS Apheresis Kit - Functionally Closed Double Needle with PAS Spike Amicus Apheresis Kit – Functionally Closed Double Needle with PAS Spike and Dual Plasma Containers AMICUS Apheresis Kit - Functionally Closed Single Needle with PAS Spike TruWave Wound packing gauze

    Establishment Types

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