Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9612051

FEI Number

3002806457

Entity Name

FENWAL INTERNATIONAL, INC.

City/State/Country

HAINA San Cristobal, DO

Establishment Address

CARRETERA SANCHEZ KM 18.5, PARQUE INDUSTRIAL ITABO ZONA FRANCA Ind. De S.C., HAINA San Cristobal --, DO

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Fresenius Kabi AG (Owner Number: 9027285)

Owner / Operator Contact Address

Else-Kroner-Str. 1, 61352 Bad Homburg, DE-NOTA NONE, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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 Bone Marrow Collection Stand Blood Component Transfusion Set Sampling Site Coupler With Needle ALYX COMPONENT COLLECTION SYSTEM AMICUS SEPARATOR 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 Plasmalink Bottle with Locking Luer Adapter CATSmart, Automated Blood Processing Autotransfusion System ALYX COMPONENT COLLECTION SYSTEM (4R5707, 4R5725) ALYX COMPONENT COLLECTION SYSTEM (6R5725) Bone Marrow Collection Kit 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 Adaptive Nomogram Transfer Pack BONE MARROW COLLECTION KIT BONE MARROW COLLECTION STAND AMICUS SEPARATOR SYSTEM 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 Ivenix Infusion System (IIS) 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 Adaptive Nomogram Transfer Pack 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 Adaptive Nomogram Transfer Pack

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2022-05-09
CAK	Microfilter, Blood Transfusion	General Hospital	Class 2	880.5440	2014-10-16
LWE	Bone Marrow Collection/Transfusion Kit	Unknown	Class 2	N/A	2016-07-11
GKT	Separator, Automated, Blood Cell, Diagnostic	Hematology	Class 2	864.9245	2014-10-17
KSR	Container, Empty, For Collection & Processing Of Blood & Blood Components	Hematology	Class 2	864.9100	2019-04-08
KSS	Supplies, Blood-Bank	Hematology	Class 1	864.9050	2014-11-05
GKT	Separator, Automated, Blood Cell, Diagnostic	Hematology	Class 2	864.9245	2014-10-17
GKT	Separator, Automated, Blood Cell, Diagnostic	Hematology	Class 2	864.9245	2014-10-15
LKN	Separator, Automated, Blood Cell And Plasma, Therapeutic	Unknown	Class U	N/A	2018-12-20
GKT	Separator, Automated, Blood Cell, Diagnostic	Hematology	Class 2	864.9245	2018-12-20
LWE	Bone Marrow Collection/Transfusion Kit	Unknown	Class 2	N/A	2017-08-15
BRZ	Set, Blood Transfusion	General Hospital	Class 2	880.5440	2021-06-25
GKT	Separator, Automated, Blood Cell, Diagnostic	Hematology	Class 2	864.9245	2014-10-16
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2016-07-28
BRZ	Set, Blood Transfusion	General Hospital	Class 2	880.5440	2014-10-15
CAK	Microfilter, Blood Transfusion	General Hospital	Class 2	880.5440	2014-10-16
FPY	Sheet, Burn	General Hospital	Class 1	880.5180	2024-11-27
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2023-11-27
GKT	Separator, Automated, Blood Cell, Diagnostic	Hematology	Class 2	864.9245	2014-10-16
KSR	Container, Empty, For Collection & Processing Of Blood & Blood Components	Hematology	Class 2	864.9100	2019-10-04
CAC	Apparatus, Autotransfusion	Anesthesiology	Class 2	868.5830	2021-02-15
GKT	Separator, Automated, Blood Cell, Diagnostic	Hematology	Class 2	864.9245	2014-10-15
LWE	Bone Marrow Collection/Transfusion Kit	Unknown	Class 2	N/A	2021-05-26
KSB	Set, Transfer (Blood/Plasma)	Hematology	Class 2	864.9875	2014-10-20
GKT	Separator, Automated, Blood Cell, Diagnostic	Hematology	Class 2	864.9245	2016-09-27
KSR	Container, Empty, For Collection & Processing Of Blood & Blood Components	Hematology	Class 2	864.9100	2023-01-04
LWE	Bone Marrow Collection/Transfusion Kit	Unknown	Class 2	N/A	2014-10-16
LKN	Separator, Automated, Blood Cell And Plasma, Therapeutic	Unknown	Class U	N/A	2014-10-17
GKT	Separator, Automated, Blood Cell, Diagnostic	Hematology	Class 2	864.9245	2014-10-17
KSR	Container, Empty, For Collection & Processing Of Blood & Blood Components	Hematology	Class 2	864.9100	2014-10-16
CAC	Apparatus, Autotransfusion	Anesthesiology	Class 2	868.5830	2011-04-29
CAC	Apparatus, Autotransfusion	Anesthesiology	Class 2	868.5830	2011-04-29
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2022-05-04
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2022-05-04
PHC	Infusion Safety Management Software	General Hospital	Class 2	880.5725	2022-05-04
KSS	Supplies, Blood-Bank	Hematology	Class 1	864.9050	2014-10-16
GKT	Separator, Automated, Blood Cell, Diagnostic	Hematology	Class 2	864.9245	2017-05-16
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2023-11-27
KSR	Container, Empty, For Collection & Processing Of Blood & Blood Components	Hematology	Class 2	864.9100	2014-10-15
KSR	Container, Empty, For Collection & Processing Of Blood & Blood Components	Hematology	Class 2	864.9100	2025-03-05
DTN	Reservoir, Blood, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4400	2005-09-14
CAK	Microfilter, Blood Transfusion	General Hospital	Class 2	880.5440	2014-10-16
GKT	Separator, Automated, Blood Cell, Diagnostic	Hematology	Class 2	864.9245	2015-11-25
GKT	Separator, Automated, Blood Cell, Diagnostic	Hematology	Class 2	864.9245	2014-10-16
KSR	Container, Empty, For Collection & Processing Of Blood & Blood Components	Hematology	Class 2	864.9100	2020-05-13
GKT	Separator, Automated, Blood Cell, Diagnostic	Hematology	Class 2	864.9245	2014-10-16
LWE	Bone Marrow Collection/Transfusion Kit	Unknown	Class 2	N/A	2014-10-15
CAK	Microfilter, Blood Transfusion	General Hospital	Class 2	880.5440	2014-10-16
KSR	Container, Empty, For Collection & Processing Of Blood & Blood Components	Hematology	Class 2	864.9100	2014-10-20

Official Correspondent

No official correspondent registered.

US Agent Details

Rhoda Lynn Valera Email: rhoda.valera@fresenius-kabi.com Phone: (847) 5502929

Related Public Records

Same Entity

Fresenius Kabi AG

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3014732157	Fresenius Kabi USA, LLC	North Andover, MA, US
3004634229	FRESENIUS HEMOCARE GMBH	Friedberg Hesse, DE
9611902	Fenwal France S.A.S.	Lacs Indre, FR
9681819	FRESENIUS KABI DEUTSCHLAND GMBH	BAD HERSFELD Hesse, DE
3008810357	Clinico Medical Sp. z o.o.	Blonie/Miekinia Dolnoslaskie, PL

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K221518	Np Medical	NP Medical nCompass Extension Set with Stabilizing Base	2022-11-03
K953474	Medikmark, Inc.	IV START KIT	1995-10-02
K972493	Nipro Medical Corp.	NIPRO DISPOSABLE SOLUTION INFUSION SET	1997-09-18
K982672	Baxter Healthcare Corp	COLLEAGUE PUMP SYRINGE ADAPTER SET	1998-09-04
K143446	Roche Diagnostics GmbH	Accu-Chek FlexLink Plus infusion set	2015-08-13

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0010-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, Product Code 21-7002-24
Z-0011-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24
Z-0012-2013	Baxter Healthcare Corp. Rt.	2	Baxter Interlink System Buretrol Solution Set with 150 mL Burette (Ball-Valve Drip Chamber); a sterile Rx IV fluid pathway device. Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.
Z-0012-2025	Smiths Medical ASD Inc.	2	CADD Medication Cassette Reservoir, 100mL, FS, YELLOW, Product Code 21-7300-24
Z-0013-2013	Baxter Healthcare Corp. Rt.	2	Baxter Interlink System Buretrol Solution Set, 117" (3.0 m), with 150 mL Burette (Ball-Valve Drip Chamber) (Non-DEHP); a sterile Rx IV fluid pathway device; Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.

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3002807090	Sterigenics Germany GmbH	Wiesbaden Hesse, DE
3013319212	ICU MEDICAL, INC.	Lake Forest, IL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9612051. Last updated year: 2026. Please use registration number 9612051 when referencing this establishment in official correspondence.