Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004548776

FEI Number

3004548776

Entity Name

FENWAL, INC.

City/State/Country

LAKE ZURICH, IL, US

Establishment Address

3 CORPORATE DR STE 300, LAKE ZURICH, IL 60047, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

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

K830755

PMA Number

N/A

All Registered Proprietary Names

AMICUS Separator System HEMATYPE SEGMENT DEVICE Plasmalink Bottle with Locking Luer Adapter Plasmalink Bottle with Locking Luer Adapter Volumat Line ALYX COMPONENT COLLECTION SYSTEM Adaptive Nomogram Bottle VOLUMAT MC AGILIA VOLUMAT LINES 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 K-Zero Needleless Connector ALYX 2RBC-LR Kit Alyx Component Collection System PLASMA TRANSFER SET Y-Type Connector Set Adaptive Nomogram Transfer Pack Aurora Xi Plasmapheresis System Software Version 1.3 ALYX COMPONENT COLLECTION SYSTEM AMICUS SEPARATOR SYSTEM PLASMACELL-C DISPOSABLE SET AURORA PLASMAPHERESIS SYSTEM CATSmart 60 IN. EXTENSION SET W/ LUER LOCKS 70 IN. EXTENSION GREEN STRIPE TUBING, LL TRIFURCATED EXTENSION, FLL, PINCH CLAMP 288 IN. EXT. SET W/FEMALE/MALE LUER Alyx Cart ALYX COMPONENT COLLECTION SYSTEM (ALYX BY FENWAL) ALYX COMPONENT COLLECTION SYSTEM (ALYX CLASSIC) ALYX COMPONENT COLLECTION SYSTEM, 4R5707 ALYX COMPONENT COLLECTION SYSTEM (ALYX BY FENWAL), 4R5725 Transfer Set AMICUS SEPARATOR, MONONUCLEAR CELL COLLECTION AMICUS Separator System CompoMat G5 Plus and CompoMaster Net G5 Plus Aurora Xi Plasmapheresis System Software Version 2 Glycerolyte 57 Solution SEPACELL PRE-STORAGE LEUKOCYTE REDUCTION SETS FOR RED CELLS ALYX COMPONENT COLLECTION SYSTEM (4R5707, 4R5725) ALYX COMPONENT COLLECTION SYSTEM (6R5725) PLASMALINK POOLING BOTTLE P1R PLASMA TREATMENT SET AS104 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 Slide Clamp Plasma Extractor DXT Relay CATSmart, Automated Blood Processing Autotransfusion System Y-TYPE BLOOD COMPONENT RECIPIENT SET Blood Component Recipient Set Blood Component Infusion Set ALYX COMPONENT COLLECTION SYSTEM CATSmart System AMICUS SEPARATOR SYSTEM AMICUS SEPARATOR SYSTEM ALYX COMPONENT COLLECTION SYSTEM ALYX RBC / Plasma Kit Aurora Xi Plasmapheresis System AMICUS SEPARATOR SYSTEM AMICUS EXCHANGE KIT AMICUS SEPARATOR SYSTEM ALYX COMPONENT COLLECTION SYSTEM (4R5707, 4R5725) ALYX 2RBC-LR Kit ALYX 2RBC DISPOSABLE SET ALYX Component Collection System ALYX INSTRUMENT DXT RELAY FOR THERAPEUTICS ALYX COMPONENT COLLECTION SYSTEM (ALYX BY FENWAL) ALYX COMPONENT COLLECTION SYSTEM (ALYX CLASSIC) ALYX PLASMA KIT HEAT SEALER CompoSeal Slim DONATION MASTER NT HEMOLIGHT PLUS COMPOGUARD DONATIONMASTER ADVANCE SOFTWARE COMPOGUARD ADVANCE 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 Alyx Component Collection System Aurora Plasmapheresis System Aurora Software Version 1.3 Upgrade Kit ALYX Component Collection System FRESENIUS KABI DONOR TUBE STRIPPER Adjustable Automatic Donor Scale Support Stand Composeal Universal Composeal Mobilea HemoSeal CompoSeal Mobilea II NPS ACCESS DEVICE MULTI-SAMPLING CONNECTOR LAB EQUIPMENT CompoSampler Aurora Plasmapheresis System Software Version 2.1 ALYX 2RBC LR Kit with Saline Spike ALYX Component Collection System AMICUS SEPARATOR SYSTEM Bone Marrow Collection Kit with Flexible Pre-Filter and Inline Filters Bone Marrow Collection Stand COMPODOCK Fenwal Plasmalink Transfer Pack Container with Luer Adapter and No Outlet Ports Adaptive Nomogram Transfer Pack PLASMACELL Xi Disposable Set Aurora Xi Plasmapheresis System COM.TEC CELL SEPARATOR TPE Plasma Exchange Set AMICUS SEPARATOR SYSTEM ALYX Component Collection System ALYX 2 RBC-LR Kit AMICUS Separator System AMICUS SEPARATOR, COLLECTION OF THREE PLATELET PRODUCTS PLASTIC STORAGE CONTAINER DXT sanabelle HME-A2 artificial nose for infants; sanabelle HME-A7 artificial nose with valve AMICUS Exchange Kit - Therapeutics Waste Transfer Set AMICUS Separator System Blood Component Filter Set with Vented Spike and Luer Adapter 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 Volumat Line CATSmart ATY-Y ADAPTER ATO OXYGENATOR LINE ATS SUCTION LINE AUTOPHERESIS-C INSTRUMENT, MODEL A-200 PLASMAPHERESIS INSTRUMENT Plasmacell-C Disposable Set C4L PLATELET SET C4 PLATELET SET Aurora Xi Plasmapheresis System, Software Version 1.2 freeflex+ Transfer Adapter Bone Marrow Collection Kit Bone Marrow Collection Container Bone Marrow Collection Stand Amicus Separator System 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 AMICUS SEPARATOR SYSTEM AMICUS APHERESIS KITS PRODUCT SAMPLE PACK AUTO-C SYSTEM AUTOPHERESIS-C PLASMAPHERESIS SYSTEM AUTOPHERESIS-C SYSTEM Aurora Xi Plasmapheresis System EXTENSION 0.2 MICRON FILTER, NEEDLEFREE BLOOD SET 170 MICRON, 2 NEEDLEFREE 6 IN. EXTENSION, 0.2 MICRON AE FILTER BLOOD SET 170 MICRON FILTER NEEDLEFREE 4-WAY HI-FLOW STOPCOCK 40 IN. EXTENSION SET, STOPCOCK 3 IN. EXTEN, 1.2 MICRON AE FILTER BLOOD SET 170 MICRON, PUMP, NEEDLEFREE 3 IN. EXTENSION, 1.2 MICRON AE FILTER EXTENSION, FLL, 0.2 MICRON FILTER MICROBORE EXTENSION, 4-WAY STOPCOCK EXTENSION, 1.2 MICRON FILTER, SLIDE CLMP Y-BLOOD SET 170 MICRONFILTER NEEDLEFREE EXTENSION, 2GANG VALVES, Y-INJ SITE EXTENSION, 3GANG ASV, NEEDLEFREE VALVES EXTENSION, CHECK VALVE, 3GANG VALVES 60 IN. MICROBORE, 0.2 MICRON FILTER LPV

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LKN	Separator, Automated, Blood Cell And Plasma, Therapeutic	Unknown	Class U	N/A	2020-09-14
GKT	Separator, Automated, Blood Cell, Diagnostic	Hematology	Class 2	864.9245	2020-09-14
KSS	Supplies, Blood-Bank	Hematology	Class 1	864.9050	2014-10-16
KSR	Container, Empty, For Collection & Processing Of Blood & Blood Components	Hematology	Class 2	864.9100	2019-04-08
KSR	Container, Empty, For Collection & Processing Of Blood & Blood Components	Hematology	Class 2	864.9100	2019-10-04
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2024-12-10
GKT	Separator, Automated, Blood Cell, Diagnostic	Hematology	Class 2	864.9245	2014-10-15
KSR	Container, Empty, For Collection & Processing Of Blood & Blood Components	Hematology	Class 2	864.9100	2025-03-05
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2013-05-23
LWE	Bone Marrow Collection/Transfusion Kit	Unknown	Class 2	N/A	2014-10-15
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2022-11-17
GKT	Separator, Automated, Blood Cell, Diagnostic	Hematology	Class 2	864.9245	2024-04-24
GKT	Separator, Automated, Blood Cell, Diagnostic	Hematology	Class 2	864.9245	2017-04-26
KSB	Set, Transfer (Blood/Plasma)	Hematology	Class 2	864.9875	2014-10-20
GKT	Separator, Automated, Blood Cell, Diagnostic	Hematology	Class 2	864.9245	2023-01-18
GKT	Separator, Automated, Blood Cell, Diagnostic	Hematology	Class 2	864.9245	2014-10-16
GKT	Separator, Automated, Blood Cell, Diagnostic	Hematology	Class 2	864.9245	2014-10-16
CAC	Apparatus, Autotransfusion	Anesthesiology	Class 2	868.5830	2020-01-24
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2015-11-13
JQC	Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use	Clinical Chemistry	Class 1	862.2050	2014-10-17
GKT	Separator, Automated, Blood Cell, Diagnostic	Hematology	Class 2	864.9245	2014-10-17
GBX	Catheter, Irrigation	General, Plastic Surgery	Class 1	878.4200	2022-11-28
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	2016-12-14
LKN	Separator, Automated, Blood Cell And Plasma, Therapeutic	Unknown	Class U	N/A	2016-12-14
KSS	Supplies, Blood-Bank	Hematology	Class 1	864.9050	2020-07-01
GKT	Separator, Automated, Blood Cell, Diagnostic	Hematology	Class 2	864.9245	2025-02-04
KSW	System, Processing For Frozen Blood	Hematology	Class 2	864.9145	2019-04-08
CAK	Microfilter, Blood Transfusion	General Hospital	Class 2	880.5440	2014-10-16
GKT	Separator, Automated, Blood Cell, Diagnostic	Hematology	Class 2	864.9245	2014-10-15
KSR	Container, Empty, For Collection & Processing Of Blood & Blood Components	Hematology	Class 2	864.9100	2014-10-15
LKN	Separator, Automated, Blood Cell And Plasma, Therapeutic	Unknown	Class U	N/A	2007-10-26
GKT	Separator, Automated, Blood Cell, Diagnostic	Hematology	Class 2	864.9245	2015-11-25
KSS	Supplies, Blood-Bank	Hematology	Class 1	864.9050	2014-11-05
MMH	Blood Establishment Computer Software And Accessories	Hematology	Class 2	864.9165	2014-10-15
CAC	Apparatus, Autotransfusion	Anesthesiology	Class 2	868.5830	2021-02-15
BRZ	Set, Blood Transfusion	General Hospital	Class 2	880.5440	2014-10-15
GKT	Separator, Automated, Blood Cell, Diagnostic	Hematology	Class 2	864.9245	2014-10-15
CAC	Apparatus, Autotransfusion	Anesthesiology	Class 2	868.5830	2016-09-22
GKT	Separator, Automated, Blood Cell, Diagnostic	Hematology	Class 2	864.9245	2014-10-16
GKT	Separator, Automated, Blood Cell, Diagnostic	Hematology	Class 2	864.9245	2014-10-15
GKT	Separator, Automated, Blood Cell, Diagnostic	Hematology	Class 2	864.9245	2014-10-16
GKT	Separator, Automated, Blood Cell, Diagnostic	Hematology	Class 2	864.9245	2017-10-12
LKN	Separator, Automated, Blood Cell And Plasma, Therapeutic	Unknown	Class U	N/A	2014-10-16
GKT	Separator, Automated, Blood Cell, Diagnostic	Hematology	Class 2	864.9245	2014-10-15
GKT	Separator, Automated, Blood Cell, Diagnostic	Hematology	Class 2	864.9245	2014-10-16
OUG	Medical Device Data System	General Hospital	Class 1	880.6310	2014-10-17
GKT	Separator, Automated, Blood Cell, Diagnostic	Hematology	Class 2	864.9245	2014-10-16
KSD	Device, Heat-Sealing	Hematology	Class 1	864.9750	1999-06-01
KSQ	Device, Blood Mixing And Blood Weighing	Hematology	Class 1	864.9195	2007-11-16
GKT	Separator, Automated, Blood Cell, Diagnostic	Hematology	Class 2	864.9245	2017-05-16
GKT	Separator, Automated, Blood Cell, Diagnostic	Hematology	Class 2	864.9245	2020-07-09
GKT	Separator, Automated, Blood Cell, Diagnostic	Hematology	Class 2	864.9245	2016-08-02
GKT	Separator, Automated, Blood Cell, Diagnostic	Hematology	Class 2	864.9245	2014-10-16
KSQ	Device, Blood Mixing And Blood Weighing	Hematology	Class 1	864.9195	1999-06-01
GHY	Hematocrit, Tube, Rack, Sealer, Holder	Hematology	Class 2	864.6400	2007-11-16
KST	System, Blood Collection, Vacuum-Assisted, Manual	Hematology	Class 1	864.9125	2014-10-17
GKT	Separator, Automated, Blood Cell, Diagnostic	Hematology	Class 2	864.9245	2019-10-04
GKT	Separator, Automated, Blood Cell, Diagnostic	Hematology	Class 2	864.9245	2015-05-12
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	2017-08-15
KSB	Set, Transfer (Blood/Plasma)	Hematology	Class 2	864.9875	2007-11-16
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	2016-09-27
LKN	Separator, Automated, Blood Cell And Plasma, Therapeutic	Unknown	Class U	N/A	2007-10-19
GKT	Separator, Automated, Blood Cell, Diagnostic	Hematology	Class 2	864.9245	2014-10-16
LKN	Separator, Automated, Blood Cell And Plasma, Therapeutic	Unknown	Class U	N/A	2019-12-09
GKT	Separator, Automated, Blood Cell, Diagnostic	Hematology	Class 2	864.9245	2019-12-09
GKT	Separator, Automated, Blood Cell, Diagnostic	Hematology	Class 2	864.9245	2014-10-16
GKT	Separator, Automated, Blood Cell, Diagnostic	Hematology	Class 2	864.9245	2017-10-17
BYD	Condenser, Heat And Moisture (Artificial Nose)	Anesthesiology	Class 1	868.5375	2017-12-22
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
GKT	Separator, Automated, Blood Cell, Diagnostic	Hematology	Class 2	864.9245	2014-10-15
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2024-02-28
CAC	Apparatus, Autotransfusion	Anesthesiology	Class 2	868.5830	2020-01-24
CAC	Apparatus, Autotransfusion	Anesthesiology	Class 2	868.5830	2011-04-29
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	2011-04-29
GKT	Separator, Automated, Blood Cell, Diagnostic	Hematology	Class 2	864.9245	2018-11-29
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2022-11-16
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	2018-01-02
GKT	Separator, Automated, Blood Cell, Diagnostic	Hematology	Class 2	864.9245	2023-05-12
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
GKT	Separator, Automated, Blood Cell, Diagnostic	Hematology	Class 2	864.9245	2020-07-23
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2015-11-13

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

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.

Similar Registrations

Registration Number	Establishment Name	Location
1722028	Terumo BCT, Inc..	Lakewood, CO, US
3005778453	FRESENIUS KABI WARRENDALE	WARRENDALE, PA, US
1720929	ISOMEDIX OPERATIONS INC.	Sandy, UT, US
1643817	ISOMEDIX OPERATIONS INC	EL PASO, TX, US
9612051	FENWAL INTERNATIONAL, INC.	HAINA San Cristobal, DO

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004548776. Last updated year: 2026. Please use registration number 3004548776 when referencing this establishment in official correspondence.