Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003464075

FEI Number

3003464075

Entity Name

NXSTAGE MEDICAL, INC.

City/State/Country

LAWRENCE, MA, US

Establishment Address

350 Merrimack St, LAWRENCE, MA 01843, US

Establishment Type(s)

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

Owner / Operator

Fresenius Medical Care Holdings, Inc. (Owner Number: 10061218)

Owner / Operator Contact Address

920 Winter Street, Waltham, MA 02451, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K183158

PMA Number

N/A

All Registered Proprietary Names

ViraGuard Viral Blocking Patient Transducer Protector NxStage Cartridge Express

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KOC	Accessories, Blood Circuit, Hemodialysis	Gastroenterology, Urology	Class 2	876.5820	2019-09-25
KPO	Dialysate Concentrate For Hemodialysis (Liquid Or Powder)	Gastroenterology, Urology	Class 2	876.5820	2019-09-20
KDI	Dialyzer, High Permeability With Or Without Sealed Dialysate System	Gastroenterology, Urology	Class 2	876.5860	2019-09-25
LGZ	Warmer, Thermal, Infusion Fluid	General Hospital	Class 2	880.5725	2019-09-20
KDI	Dialyzer, High Permeability With Or Without Sealed Dialysate System	Gastroenterology, Urology	Class 2	876.5860	2019-09-25
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2019-09-25
FIE	Needle, Fistula	Gastroenterology, Urology	Class 2	876.5540	2019-09-25
FMI	Needle, Hypodermic, Single Lumen	General Hospital	Class 2	880.5570	2019-09-25
FIB	Protector, Transducer, Dialysis	Gastroenterology, Urology	Class 2	876.5820	2019-09-25
FOX	Stand, Infusion	General Hospital	Class 1	880.6990	2019-09-25
KDI	Dialyzer, High Permeability With Or Without Sealed Dialysate System	Gastroenterology, Urology	Class 2	876.5860	2019-09-25
FIE	Needle, Fistula	Gastroenterology, Urology	Class 2	876.5540	2019-09-25
KDI	Dialyzer, High Permeability With Or Without Sealed Dialysate System	Gastroenterology, Urology	Class 2	876.5860	2019-09-25
KDI	Dialyzer, High Permeability With Or Without Sealed Dialysate System	Gastroenterology, Urology	Class 2	876.5860	2019-09-25
KOC	Accessories, Blood Circuit, Hemodialysis	Gastroenterology, Urology	Class 2	876.5820	2019-09-25
FKR	Subsystem, Proportioning	Gastroenterology, Urology	Class 2	876.5820	2019-09-25
FKR	Subsystem, Proportioning	Gastroenterology, Urology	Class 2	876.5820	2019-09-25
FIE	Needle, Fistula	Gastroenterology, Urology	Class 2	876.5540	2019-09-25
KPO	Dialysate Concentrate For Hemodialysis (Liquid Or Powder)	Gastroenterology, Urology	Class 2	876.5820	2024-01-30
KDI	Dialyzer, High Permeability With Or Without Sealed Dialysate System	Gastroenterology, Urology	Class 2	876.5860	2024-05-08
KDI	Dialyzer, High Permeability With Or Without Sealed Dialysate System	Gastroenterology, Urology	Class 2	876.5860	2019-09-25

Official Correspondent

Rachel Lloyd

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Fresenius Medical Care Holdings, Inc.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
9616074	MEDIMEXICO, S. DE R.L. DE C.V.	TIJUANA Baja California, MX

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K811830	Cordis Corp.	C-DAK DUO-FLUX ARTIFICIAL KIDNEY	1981-09-21
K070320	Edwards Lifesciences Services GmbH	EDWARDS AQUARIUS HEMOFILTRATION SYSTEM, MODEL ABM 01	2007-06-07
K150880	Outset Medical	Tablo Console with Wireless Capability	2015-05-01
K812404	Nu Tech Medical Systems	BUTTERFLY NEEDLE ASSEMBLY	1981-09-09
K915174	Jms Co., Ltd.	JMS APHERESIS NEEDLE	1993-03-02

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0005-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/OUT NEEDLE, Part Number 15-R010-0, 100 per box, 12 boxes to a case
Z-0006-2024	Fresenius Medical Care Holdings, Inc.	2	10ML SYRINGE LUER LOCK W/NEEDLE, Part Number 15-10ML-0, 100 per box, 12 boxes per case
Z-0007-2024	Fresenius Medical Care Holdings, Inc.	2	3ML Syringe Luer Lock with needle 20GX1, Part Number 15-03ML-0, 100 per box, 24 boxes per case
Z-0028-2024	Fresenius Medical Care Holdings, Inc.	2	2008T Hemodialysis SYS, with CDX
Z-0029-2024	Fresenius Medical Care Holdings, Inc.	2	2008T Hemodialysis System without CDX

Similar Registrations

Registration Number	Establishment Name	Location
3023981687	Erika of Texas	Pharr, TX, US
9611824	FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH	SCHWEINFURT Bavaria, DE
8030665	ERIKA DE REYNOSA, S.A. DE C.V.	CD, REYNOSA Tamaulipas, MX
2020550	KARL STORZ ENDOSCOPY-AMERICA, INC.	Auburn, MA, US
3027859369	M.E.Nikkiso Vietnam Co., Ltd.	Quang Ngai, VN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003464075. Last updated year: 2026. Please use registration number 3003464075 when referencing this establishment in official correspondence.