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Data / Medical devices / Dominican Republic / Fenwal International, Inc.

Fenwal International, Inc.: FDA-registered device maker in HAINA San Cristobal, Dominican Republic, 12 510(k) clearances

Fenwal International, Inc. is registered with the FDA (registration 9612051) in HAINA San Cristobal, Dominican Republic. It lists 21 device types. The FDA files 12 510(k) clearances under its listings, the newest dated November 10, 2021. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch Fenwal International, Inc.
FDA registration number
9612051
FEI number
3002806457
Address
CARRETERA SANCHEZ KM 18.5 PARQUE INDUSTRIAL ITABO ZONA FRANCA Ind. De S.C., HAINA San Cristobal, Dominican Republic, --
Owner or operator
Fresenius Kabi AG (9027285)
Roles
Contract sterilizer, Manufacturer
First device listed
September 14, 2005
Registered through
2026
Brand names listed
ALYX 2RBC DISPOSABLE SET, ALYX 2RBC-LR Kit, ALYX COMPONENT COLLECTION SYSTEM, ALYX COMPONENT COLLECTION SYSTEM (4R5707, 4R5725), ALYX COMPONENT COLLECTION SYSTEM (6R5725), ALYX Component Collection System, ALYX INSTRUMENT, AMICUS APHERESIS KIT - DOUBLE NEEDLE W/PAS CONNECTOR and more

Devices it lists

DeviceProduct codeClassRoleSource
Apparatus, AutotransfusionCAC2Manufactureraccessdata.fda.gov
Bandage, ElasticFQM1Contract sterilizeraccessdata.fda.gov
Bone Marrow Collection/Transfusion KitLWE2Manufactureraccessdata.fda.gov
Catheter, Continuous FlushKRA2Contract sterilizeraccessdata.fda.gov
Container, Empty, For Collection & Processing Of Blood & Blood ComponentsKSR2Manufactureraccessdata.fda.gov
Gauze / Sponge,Nonresorbable For External UseNAB1Contract sterilizeraccessdata.fda.gov
Gauze/Sponge, Internal, X-Ray DetectableGDY1Contract sterilizeraccessdata.fda.gov
Hemostatic Wound Dressing Without Thrombin Or Other BiologicsQSYUContract sterilizeraccessdata.fda.gov
Infusion Safety Management SoftwarePHC2Manufactureraccessdata.fda.gov
Microfilter, Blood TransfusionCAK2Manufactureraccessdata.fda.gov
Pump, InfusionFRN2Manufactureraccessdata.fda.gov
Reservoir, Blood, Cardiopulmonary BypassDTN2Manufactureraccessdata.fda.gov
Separator, Automated, Blood Cell And Plasma, TherapeuticLKNUManufactureraccessdata.fda.gov
Separator, Automated, Blood Cell, DiagnosticGKT2Manufactureraccessdata.fda.gov
Set, Administration, IntravascularFPA2Manufactureraccessdata.fda.gov
Set, Blood TransfusionBRZ2Manufactureraccessdata.fda.gov
Set, Transfer (Blood/Plasma)KSB2Manufactureraccessdata.fda.gov
Sheet, BurnFPY1Contract sterilizeraccessdata.fda.gov
Splint, Intranasal SeptalLYA1Contract sterilizeraccessdata.fda.gov
Supplies, Blood-BankKSS1Manufactureraccessdata.fda.gov
Transducer, Pressure, Catheter TipDXO2Contract sterilizeraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
November 10, 2021K213089Ivenix Infusion System, LVP Epidural Administraion Set NRFit ConnectorFPASubstantially EquivalentIvenix, Inc.accessdata.fda.gov
February 11, 2021K210089CATSmart, Automated Blood Processing Autotransfusion SystemCACSubstantially EquivalentFresenius Kabi AGaccessdata.fda.gov
June 7, 2019K183311Ivenix Infusion System (IIS)FRNSubstantially EquivalentIvenix, Inc.accessdata.fda.gov
December 4, 2018K180615AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood Component Filter Set With Vented Spike and Luer AdapterLKNSubstantially EquivalentFresenius Kabi USA,Llcaccessdata.fda.gov
June 10, 2014K141019AMICUS SEPARATOR SYSTEM/ AMICUS SEPERATOR SYSTEM;REFURBISHEDLKNSubstantially EquivalentFenwal, Inc.accessdata.fda.gov
March 22, 2012K111702AMICUS SEPARATOR SYSTEM- USE IN THERAPEUTIC PLASMA EXCHANGE AND FILTER SET FOR AMICUS TPELKNSubstantially EquivalentFenwal, Inc.accessdata.fda.gov
March 3, 2008K073339BLOOD COMPONENT RECIPIENT SET WITH STANDARD SIZE FILTER AND INFUSION SET WITH SIDE ARM LUER CONNECTORBRZSubstantially EquivalentFenwal, Inc.accessdata.fda.gov
June 29, 1999K984586FRESENIUS ATR40 AND ATR120 AUTOTRANSFUSION RESERVOIRSDTNSubstantially EquivalentFresenius Hemotechnology, Inc.accessdata.fda.gov
February 1, 1999K984233C.A.T.S AUTOTRANSFUSION ACCESSORIES, MODELS ATS SUCTION LINE, ATY Y-ADAPTER, AND ATO OXYGENATOR LINECACSubstantially EquivalentFresenius Hemotechnology, Inc.accessdata.fda.gov
June 13, 1997K971274C.A.T.S CONTINUOUS AUTOTRANSFUSION SYSTEM, AT1 AUTOTRANSFUSION SET, PSQ SETCACSubstantially EquivalentFresenius AGaccessdata.fda.gov
October 26, 1990K904223SEPACELL(R) R-200/500 LEUKOCYTE REMOVAL RECIP SETSCAKSubstantially EquivalentBaxter Healthcare Corpaccessdata.fda.gov
November 6, 1987K871198BONE MARROW COLLECTION KIT AND STANDLWESubstantially EquivalentBaxter Healthcare Corpaccessdata.fda.gov

Compare with other makers

Updated November 10, 2021. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.