Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1416980

FEI Number

1416980

Entity Name

BAXTER HEALTHCARE CORPORATION

City/State/Country

ROUND LAKE, IL, US

Establishment Address

25212 W. ILLINOIS ROUTE 120, ROUND LAKE, IL 60073, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

BAXTER HEALTHCARE CORPORATION (Owner Number: 1417572)

Owner / Operator Contact Address

One Baxter Parkway, Deerfield, IL 60015, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K161323

PMA Number

N/A

All Registered Proprietary Names

Recothrom Irrigating (Non-Dental) Syringe - Ear Wash System and accessories DuploReach Evacuated Container None MICROMIX BCR COMPOUNDER All-In-One Two Chamber Container Automix 3+3/AS Compounder System REPEATER PUMP Extension Set MICROMIX COMPOUNDER AN Abacus Luer Lock Universal Spike EM2400 Pharmacy Compounder INTELLIFILL I.V. ExactaMix Pro 2400 Display Module - Refurbished ExactaMix Pro 2400 Display Module ExactaMix Pro 1200 Display Module - Refurbished ExactaMix Pro 1200 Display Module LOGIX Transfer Set REPEATER PUMP Tube Sets AUTOMIX 3+3 COMPOUNDER Duo-Vent Clearlink Interlink Solutions Administration Sets with 0.2 Micron Filter Continu-Flo ALTAPORE PERI-GUARD and SUPPLE PERI-GUARD Duoset Duploject Duplocath Veritas Collagen Matrix Actifuse Actifuse Spectrum IQ Infusion System with Dose IQ Safety Software Interlink Clearlink Buretrol Buretrol Solution Sets Spectrum IQ Infusion System with Dose IQ Safety Software (3570009) Galaxy Mini-Bag Plus MINIBAG PLUS CONTAINER REPEATER PUMP Tube Sets and Connectors Dispencing Pins RAPIDFILL Infusion Set Flo-Thru Gem Flow Now (GEM2770-FN) PCEA Syringe Set GEM Flow Coupler Device and System Flo-Rester PERI-STRIPS Dry Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP Technology Sub-Q-Set Subcutaneous Infusion Set Sub-Q-Set Seprafilm Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MIS Ostene PCA Syringe Sets Solution Set w/1.2 Micron Air Eliminating Filter Interlink Clearlink RAPIDFILL Tube Set Non-DEHP IV Fat Emulsion Administration Sets DUPLOJECT EASY-PREP SYSTEM Multirate Infusor LV Multirate Infusor SV Baxter Pain Mate Pain Mgt System GEM FLOW COUPLER Monitor (GEM2010M-1) GEM Flow COUPLER Monitor Power Cord Peri-Strips Dry with Veritas Instrument Trays GEM ZIPCLIP Microvascular Anastomotic Device GEM Biover Clamps Actifuse Flow Paclitaxel Sets Aviva Viaflex Additive Cap Interlink Universal Vial Adapter Clearlink Interlink Bard Epidural Spike Tubing Set Valve Controller & Tube Sets for MICROMACRO Compounder GEM Flow Coupler Device and System Ostene Blood Administration Sets 3 Lead Ext w/2 Interlink Inject Sit Interlink Clearlink 3 Port Adapter Dose IQ Safety Software EASYGRIP FLO-41 Precision MIS Delivery System Solution Administration Sets Micro-Volume Interlink MICRO-VOLUME Extension Set Flo-Rester Vessel Sizer DermaClose Continous External Tissue Expander DermaClose XL Continuous External Tissue Expander Floseal EXACTAMIX EVA TPN Bags Tubing Sets for Pharmacy Compounder Anastomotic Instrument None Ophthalmoscope, battery-powered Vascular Probe NEOTHRIVE Oral Liquid Dispenser EXACTAMED KWIK VIAL ADAPTACAP EXACTAMED Oral Dispenser Oral Liquid Bottle Adapter NICOM Electrodes Prewired Electrode of Cheetah Medical Starling Sensors Electrode Cheetah Sensors Baxter Starling Sensor Pre-wired NICOM Sensor NICOM sensor Actifuse ABX Actifuse Solution Sets, Extension Sets Continu-Flo Duo-Vent Actifuse Flow Duo-Vent Clearlink Interlink Clearlink Luer Activated Valve Forceps Vascu-Guard Stopcock and I.V. Solution Administration Sets with Stopcocks Clearlink Continu-Flo Interlink Coseal Surgical Sealant Fibrinotherm Actifuse Novum IQ Syringe Pump IntraVia Container Empty IntraVia PerClot Polysaccharide Hemostatic System Ostene Peri-Strips Dry with Veritas Collagen Matrix with Secure Grip Techonology (PSDV-SG) Tissomat and Spray Set Interlink Continu-Flo Duo-Vent Interlink System Intravascular Administration Sets Clearlink System Solution Set Bard Epidural Spike Tubing Set Vascu-Guard Vascular Repair Patch Intravascular Administration Sets with Stopcock and Manifold Neutral Luer Activated Device (One-Link Needle-free IV Connector) and Extension Sets with One-Link Needle-free IV Connec One-Link Actifuse Shape Ostene Dura-Guard-Dural Repair Patch Solution Set Secondary Medication Set ContinuFlo Solution Set Control-A-Flo Duo-Vent Clearlink Continu-Flo Interlink Intravascular Extension Sets and Accessories Continu-Flo Clearlink Interlink Control-A-Flo I.V. Administration Set with Control-A-Flo Regulator Blood Administration Set GEM Flow Coupler Device and System Sterile Luer Lock-to-Urethral Tip Adapter Sterile Luer Lock-to-Catheter Tip Adapter VIAL-MATE Reconstitution Device Viaflex Vial-Mate Solution Set for Epidural Use

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KYZ	Syringe, Irrigating (Non Dental)	General Hospital	Class 1	880.6960	2014-03-13
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2007-12-03
GCY	Apparatus, Suction, Single Patient Use, Portable, Nonpowered	General, Plastic Surgery	Class 1	878.4680	1994-01-31
NEP	System/Device, Pharmacy Compounding	General Hospital	Class 2	880.5440	2007-07-05
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2016-01-11
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2020-04-16
DXZ	Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene	Cardiovascular	Class 2	870.3470	2023-04-28
FTM	Mesh, Surgical	General, Plastic Surgery	Class 2	878.3300	2023-04-28
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2015-01-22
FTM	Mesh, Surgical	General, Plastic Surgery	Class 2	878.3300	2015-01-22
PAJ	Mesh, Surgical, Non-Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed	General, Plastic Surgery	Class 2	878.3300	2015-01-22
OXB	Mesh, Surgical, Collagen, Thoracic, Chest Wall Reconstruction	General, Plastic Surgery	Class 2	878.3300	2015-01-22
OXE	Mesh, Surgical, Collagen, Staple Line Reinforcement	General, Plastic Surgery	Class 2	878.3300	2015-01-22
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2015-01-22
LYC	Bone Grafting Material, Synthetic	Dental	Class 2	872.3930	2015-01-22
PHC	Infusion Safety Management Software	General Hospital	Class 2	880.5725	2018-05-14
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2018-05-14
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2013-01-15
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2025-07-31
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	Class 1	862.2050	1994-12-27
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2012-03-02
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2012-03-02
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2012-03-02
DXC	Clamp, Vascular	Cardiovascular	Class 2	870.4450	2015-01-22
ITX	Transducer, Ultrasonic, Diagnostic	Radiology	Class 2	892.1570	2024-11-04
IYN	System, Imaging, Pulsed Doppler, Ultrasonic	Radiology	Class 2	892.1550	2024-11-04
PWH	Administrations Sets With Neuraxial Connectors	General Hospital	Class 2	880.5440	2024-06-12
DPW	Flowmeter, Blood, Cardiovascular	Cardiovascular	Class 2	870.2100	2015-12-07
MVR	Device, Anastomotic, Microvascular	General, Plastic Surgery	Class 2	878.4300	2015-12-07
DXC	Clamp, Vascular	Cardiovascular	Class 2	870.4450	2015-01-22
FTM	Mesh, Surgical	General, Plastic Surgery	Class 2	878.3300	2021-11-18
OXE	Mesh, Surgical, Collagen, Staple Line Reinforcement	General, Plastic Surgery	Class 2	878.3300	2021-11-18
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2007-12-03
MCN	Barrier, Absorbable, Adhesion	Unknown	Class 3	N/A	2020-04-01
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2025-11-20
MTJ	Wax, Bone	Unknown	Class U	N/A	2015-01-22
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2023-01-05
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2007-12-03
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2012-03-02
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2017-09-26
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2007-12-03
MEB	Pump, Infusion, Elastomeric	General Hospital	Class 2	880.5725	2007-12-03
DPW	Flowmeter, Blood, Cardiovascular	Cardiovascular	Class 2	870.2100	2019-09-20
MVR	Device, Anastomotic, Microvascular	General, Plastic Surgery	Class 2	878.4300	2019-09-20
FTM	Mesh, Surgical	General, Plastic Surgery	Class 2	878.3300	2015-01-22
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	General Hospital	Class 2	880.6850	2015-12-07
FZP	Clip, Implantable	General, Plastic Surgery	Class 2	878.4300	2025-02-18
MVR	Device, Anastomotic, Microvascular	General, Plastic Surgery	Class 2	878.4300	2015-12-07
DXC	Clamp, Vascular	Cardiovascular	Class 2	870.4450	2023-12-05
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2015-01-22
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2017-01-17
KPE	Container, I.V.	General Hospital	Class 2	880.5025	2011-07-14
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2007-12-03
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2007-12-03
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2012-03-02
DPW	Flowmeter, Blood, Cardiovascular	Cardiovascular	Class 2	870.2100	2015-12-07
MVR	Device, Anastomotic, Microvascular	General, Plastic Surgery	Class 2	878.4300	2015-12-07
MTJ	Wax, Bone	Unknown	Class U	N/A	2015-01-22
BRZ	Set, Blood Transfusion	General Hospital	Class 2	880.5440	2022-12-12
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2007-12-03
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2009-11-06
PHC	Infusion Safety Management Software	General Hospital	Class 2	880.5725	2024-04-01
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2020-01-14
FPB	Filter, Infusion Line	General Hospital	Class 2	880.5440	2025-04-02
FMG	Stopcock, I.V. Set	General Hospital	Class 2	880.5440	2025-04-02
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2025-04-02
FPB	Filter, Infusion Line	General Hospital	Class 2	880.5440	2012-03-16
DWP	Dilator, Vessel, Surgical	Cardiovascular	Class 2	870.4475	2015-01-22
MKY	System, Skin Closure	General, Plastic Surgery	Class 1	878.4320	2017-12-22
PMX	Absorbable Collagen Hemostatic Agent With Thrombin	General, Plastic Surgery	Class 3	878.4490	2007-07-03
LMF	Agent, Absorbable Hemostatic, Collagen Based	General, Plastic Surgery	Class 3	878.4490	2007-07-03
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2012-03-02
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2015-11-24
HLJ	Ophthalmoscope, Battery-Powered	Ophthalmic	Class 2	886.1570	2023-10-11
DWP	Dilator, Vessel, Surgical	Cardiovascular	Class 2	870.4475	2015-01-22
KYX	Dispenser, Liquid Medication	General Hospital	Class 1	880.6430	1991-12-31
DXG	Computer, Diagnostic, Pre-Programmed, Single-Function	Cardiovascular	Class 2	870.1435	2022-11-16
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2015-01-22
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2015-01-22
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2014-08-25
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2018-09-11
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2011-10-28
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2015-12-07
DXZ	Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene	Cardiovascular	Class 2	870.3470	2015-01-22
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2013-03-07
FMG	Stopcock, I.V. Set	General Hospital	Class 2	880.5440	2013-03-07
NBE	Sealant, Polymerizing	Unknown	Class 3	N/A	2015-01-22
JRG	Block, Heating	Clinical Chemistry	Class 1	862.2050	2015-01-22
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2015-01-22
LZH	Pump, Infusion, Enteral	General Hospital	Class 2	880.5725	2024-09-06
FRN	Pump, Infusion	General Hospital	Class 2	880.5725	2024-09-06
KPE	Container, I.V.	General Hospital	Class 2	880.5025	2007-12-03
LMG	Agent, Absorbable Hemostatic, Non-Collagen Based	General, Plastic Surgery	Class 3	878.4490	2023-05-25
MTJ	Wax, Bone	Unknown	Class U	N/A	2015-01-22
FTM	Mesh, Surgical	General, Plastic Surgery	Class 2	878.3300	2019-12-20
OXE	Mesh, Surgical, Collagen, Staple Line Reinforcement	General, Plastic Surgery	Class 2	878.3300	2019-12-20
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2015-01-22
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2013-01-15
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2021-11-11
PSQ	Intracardiac Patch Or Pledget, Biologically Derived	Cardiovascular	Class 2	870.3470	2022-11-11
FMG	Stopcock, I.V. Set	General Hospital	Class 2	880.5440	2023-04-19
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2013-12-20
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2015-01-22
MTJ	Wax, Bone	Unknown	Class U	N/A	2015-01-22
GXQ	Dura Substitute	Neurology	Class 2	882.5910	2015-01-22
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2007-12-03
FPB	Filter, Infusion Line	General Hospital	Class 2	880.5440	2025-03-05
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2025-03-05
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2012-07-30
BRZ	Set, Blood Transfusion	General Hospital	Class 2	880.5440	2021-06-17
DPW	Flowmeter, Blood, Cardiovascular	Cardiovascular	Class 2	870.2100	2015-04-10
MVR	Device, Anastomotic, Microvascular	General, Plastic Surgery	Class 2	878.4300	2015-04-10
EYI	Adaptor, Ureteral Catheter	Gastroenterology, Urology	Class 1	876.5130	2026-01-20
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2015-02-09
FPA	Set, Administration, Intravascular	General Hospital	Class 2	880.5440	2016-12-07

Official Correspondent

Maha Nolasco

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

BAXTER HEALTHCARE CORPORATION

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3014226707	BARDY DIAGNOSTICS, INC.	Bellevue, WA, US
3019257308	VIDEOMED SRL	LIMENA Padova, IT
1314492	Baxter Healthcare Corporation	MEDINA, NY, US
3007143268	Baxter Medical Systems GmbH + Co. KG	SAALFELD Thuringia, DE
8010130	BAXTER SA	LESSINES Hainaut, BE

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K880350	Honway International Co.	YUE/FA DISPOSABLE SYRINGE	1988-02-16
K003571	Terumo Medical Corp.	SERONO FOR USE WITH GONAL-F 1200IU MULTI-DOSE ONLY AT 600IU/ML SYRINGE	2001-02-12
K883982	Iberhospitex, S.A.	DRENOVAC	1989-02-23
K221518	Np Medical	NP Medical nCompass Extension Set with Stabilizing Base	2022-11-03
K953474	Medikmark, Inc.	IV START KIT	1995-10-02

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2011	Baxter Healthcare Corp. Rt.	2	Baxter Colleague Single Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery Division. Product Codes: 2M8151, 2M8161, and 2M9161.
Z-0002-2011	Baxter Healthcare Corp. Rt.	2	Baxter Colleague Triple Channel Volumetric Infusion Pumps. Baxter Healthcare Corporation, Medication Delivery Division. Product codes: 2M8153, and 2M8163.
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-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.
Z-0014-2013	Baxter Healthcare Corp. Rt.	2	Baxter Clearlink System Buretrol Solution Set, 115" (2.9 m) with 150 mL Clearlink 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-0015-2013	Baxter Healthcare Corp. Rt.	2	Baxter Clearlink System Buretrol Solution Set, 115" (2.9 m) with 150 mL Clearlink 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.
Z-0033-06	Baxter Healthcare Corp. Rt.	N/A	Baxter''s Patient Care System (BPCS) software, composed of Pharmacy Management - Inpatient - product code 2M5013, Point of Care - product code 2M5014 and Management Reports - product code 2M5015; Baxter Healthcare Corporation, 1 Baxter Parkway, Deerfield, IL 60015, USA, made in Canada

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1416980. Last updated year: 2026. Please use registration number 1416980 when referencing this establishment in official correspondence.