NXSTAGE MEDICAL, INC.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3003464075	3003464075	NXSTAGE MEDICAL, INC.	1	N	2026-01-01	350 Merrimack St LAWRENCE MA US 01843

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDID	Product	Phone	Email
00842289103245	NxStage PureFlow Solution - RFP-207-C	1-866-697-8243	info@nxstage.com
00842289103252	NxStage PureFlow Solution - RFP-204-C	1-866-697-8243	info@nxstage.com
M535FW300WW0	EXPRESS FLUID WARMER - FW-300-WW	1-866-697-8243	info@nxstage.com
M535NX06420	NXSTAGE LEAK DETECTION SENSOR AND TRAY ACCESSORY KIT - NX0642	1-866-697-8243	info@nxstage.com
M535NX100010B0	VersiHD - NX1000-10-B	1-866-697-8243	info@nxstage.com
M535NX1272	NxStage Dosing Calculator - NX1272	1-866-697-8243	info@nxstage.com
M535NX13480	NXSTAGE LEAK DETECTION SENSOR AND TRAY ACCESSORY KIT - NX1348	1-866-697-8243	info@nxstage.com
M535NX13730	NXSTAGE LEAK DETECTION SENSOR AND TRAY ACCESSORY KIT - NX1373	1-866-697-8243	info@nxstage.com

nxstage.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
233341	1702661745	K994306	REVERSO	KOC	2000-03-20
233341	1361216650	K990803	MEDISYSTEMS BUTTONHOLE NEEDLE SETS	FIE	2000-01-06
233341	1702332301	K983076	MEDISYSTEMS TRANSDUCER PROTECTOR	FIB	1998-11-25
233341	1087267670	K971860	MEDISYSTEMS DIALYSIS PRIMING SETS	KOC	1997-08-18
233341	1999387544	K932074	MEDISYSTEMS APHERESIS NEEDLE WITH GUARD	FIE	1994-02-18
233341	1707249300	K910734	MEDISYSTEMS HEMODIALYSIS FISTULA SET	FIE	1991-06-20
233341	1000928583	K910733	MEDISYSTEMS ANTI-STICK INJECTION SITE NEEDLE	FMI	1991-06-06
233341	1718927588	K252377	NxStage System One with NxView	KDI	2026-05-15
233341	1092015183	K233213	NxStage PureFlow Solution	KPO	2024-01-18
233341	1039744023	K232803	NxStage System One with Cartridge Express (CAR-170-E and CAR-172-E)	KDI	2024-03-14
233341	2013832094	K230632	VersiHD with GuideMe software	KDI	2023-08-11
233341	1301023780	K183158	NxStage Cartridge Express with Speedswap	KDI	2019-08-09
233341	2024518185	K181991	NxStage Connected Health System	FKP	2018-09-26
233341	1149518252	K170469	NxStage System One Plus	KDI	2017-05-09
233341	1147480381	K143313	NxStage Therapeutic Plasma Exchange (TPE) Cartridge	KDI	2015-03-20
233341	1301992030	K140623	NXSTAGE EXPRESS FLUID WARMER	FLA	2014-06-16
233341	2016998166	K140571	NXSTAGE PUREFLOW SL	FKR	2014-05-15
233341	1341755389	K140526	NXSTAGE SYSTEM ONE	KDI	2014-05-19
233341	1093993471	K134019	MEDISYSTEMS ONESITE DUAL LUMEN NEEDLE WITH MASTERGUARD ANTI-STICK NEEDLE PROTECTOR, MEDISYSTEMS ONESITE DUAL LUMEN BUTTO	FIE	2014-09-11
233341	1622258951	K133547	NXSTAGE SYSTEM ONE WITH NXVIEW	KDI	2014-03-03
233341	1181589910	K132602	STREAMLINE EXPRESS	KDI	2014-02-04
233341	1191309197	K131739	NXSTAGE CONNECTED HEALTH SYSTEM	FKP	2013-10-10
233341	1350041050	K130460	NXSTAGE DOSING CALCULATOR	FKP	2013-07-11
233341	1034331741	K122051	NXSTAGE SYSTEM ONE	KDI	2013-04-23
233341	1669400944	K113023	STREAMLINE AIRLESS SYSTEM SET WITH PRE-ATTACHED DIALYZER	KDI	2012-12-21
233341	1001569095	K111174	NXSTAGE PUREFLOW SL	FKR	2011-09-19
233341	2005077600	K093069	NXSTAGE SYSTEM ONE WITH THERAPEUTIC PLASMA EXCHANGE CARTRIDGE	KDI	2010-10-23
233341	1036511449	K081043	LEAK DETECTION SENSOR AND TRAY ACCESSORY KIT	KOC	2008-07-07
233341	1083951392	K080807	BLOOD TUBING SETS (STERILE FLUID PATH)	FJK	2008-07-18
233341	1189330707	K071263	NXSTAGE TRAVEL WARMER, MODELS TW-400 & FWS-500	KDI	2007-08-24
233341	1239091507	K053286	MODIFICATION TO: NXSTAGE PUREFLOW-B SOLUTION	KPO	2005-12-22
233341	1848642188	K050525	NXSTAGE SYSTEM ONE	KDI	2005-06-24
233341	1132442289	K040074	ONEVIEW INTERFACE	FKP	2004-04-08
233341	1145346268	K033386	NXSTAGE PUREFLOW SOLUTION	KPO	2003-11-26
233341	1783571847	K012832	COMFORTMATE FLUID WARMING SYSTEM, MODEL # FW-200; COMFORTMATE DISPORSABLE DISPOSABLE WARMING SET, MODEL #FWS-200	LGZ	2001-10-24
233341	1423019493
233341	1900951620
233341	1116350148

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
KDI	14	2026-05-15
FKP	4	2018-09-26
FIE	4	2014-09-11
KPO	3	2024-01-18
KOC	3	2008-07-07
FKR	2	2014-05-15
FLA	1	2014-06-16
FJK	1	2008-07-18
LGZ	1	2001-10-24
FIB	1	1998-11-25
FMI	1	1991-06-06

PMN#

NxStage System One with Cartridge Express (CAR-170-E and CAR-172-E)
2024-03-14
Nxstage Medical, Inc.
NxStage PureFlow Solution
2024-01-18
Nxstage Medical, Inc.
VersiHD with GuideMe software
2023-08-11
Nxstage Medical, Inc.
NxStage Cartridge Express With Speedswap
2019-08-09
NxStage Medical, Inc.
NxStage Connected Health System
2018-09-26
NxStage Medical, Inc
NxStage System One
2017-08-24
NxStage Medical, Inc.
NxStage System One Plus
2017-05-09
NxStage Medical, Inc
NxStage System One
2015-06-04
NXSTAGE MEDICAL, INC.
NxStage Therapeutic Plasma Exchange (TPE) Cartridge
2015-03-20
NxStage Medical, Inc.
NXSTAGE SYSTEM ONE
2014-12-19
NXSTAGE MEDICAL, INC.
MEDISYSTEMS ONESITE DUAL LUMEN NEEDLE WITH MASTERGUARD ANTI-STICK NEEDLE PROTECTOR, MEDISYSTEMS ONESITE DUAL LUMEN BUTTO
2014-09-11
NXSTAGE MEDICAL, INC.
NXSTAGE EXPRESS FLUID WARMER
2014-06-16
NXSTAGE MEDICAL, INC.
NXSTAGE SYSTEM ONE
2014-05-19
NXSTAGE MEDICAL, INC.
NXSTAGE PUREFLOW SL
2014-05-15
NXSTAGE MEDICAL, INC.
NXSTAGE SYSTEM ONE WITH NXVIEW
2014-03-03
NXSTAGE MEDICAL, INC.
STREAMLINE EXPRESS
2014-02-04
NXSTAGE MEDICAL, INC.
NXSTAGE 1.6M2 DIALYZER
2013-12-27
NXSTAGE MEDICAL, INC.
NXSTAGE CONNECTED HEALTH SYSTEM
2013-10-10
NXSTAGE MEDICAL, INC.
NXSTAGE DOSING CALCULATOR
2013-07-11
NXSTAGE MEDICAL, INC.
NXSTAGE SYSTEM ONE
2013-04-23
NXSTAGE MEDICAL, INC.
NXSTAGE SYSTEM ONE LOW VOLUME CARTRIDGE EXPRESS
2013-03-07
NXSTAGE MEDICAL, INC.
STREAMLINE AIRLESS SYSTEM SET WITH PRE-ATTACHED DIALYZER
2012-12-21
NXSTAGE MEDICAL, INC.
NXSTAGE PUREFLOW SL
2011-09-19
NXSTAGE MEDICAL, INC.
NXSTAGE SYSTEM ONE WITH THERAPEUTIC PLASMA EXCHANGE CARTRIDGE
2010-10-23
NXSTAGE MEDICAL, INC.
BLOOD TUBING SETS (STERILE FLUID PATH)
2009-02-10
NXSTAGE MEDICAL, INC.
NXSTAGE PUREFLOW SL
2008-10-15
NXSTAGE MEDICAL, INC.
BLOOD TUBING SETS (STERILE FLUID PATH)
2008-07-18
NXSTAGE MEDICAL, INC.
LEAK DETECTION SENSOR AND TRAY ACCESSORY KIT
2008-07-07
NXSTAGE MEDICAL, INC.
NXSTAGE TRAVEL WARMER, MODELS TW-400 & FWS-500
2007-08-24
NXSTAGE MEDICAL, INC.
NXSTAGE CARTRIDGE EXPRESS
2006-07-31
NXSTAGE MEDICAL, INC.
NXSTAGE DIALYSATE PREPARATION MODULE
2006-03-31
NXSTAGE MEDICAL, INC.
MODIFICATION TO: NXSTAGE PUREFLOW-B SOLUTION
2005-12-22
NXSTAGE MEDICAL, INC.
NXSTAGE SYSTEM ONE
2005-06-24
NXSTAGE MEDICAL, INC.
MODIFICATION TO NXSTAGE CARTRIDGE EXPRESS
2005-06-13
NXSTAGE MEDICAL, INC.
NXSTAGE DIALYSATE PREPARATION MODULE, MODEL NX0269
2005-03-17
NXSTAGE MEDICAL, INC.
NXSTAGE PUREFLOW-B SOLUTION
2004-08-27
NXSTAGE MEDICAL, INC.
NXSTAGE SYSTEM ONE
2004-07-02
NXSTAGE MEDICAL, INC.
MODIFICATION TO NXSTAGE SYSTEM ONE
2004-05-26
NXSTAGE MEDICAL, INC.
ONEVIEW INTERFACE
2004-04-08
NXSTAGE MEDICAL, INC.
NXSTAGE PUREFLOW SOLUTION
2003-11-26
NXSTAGE MEDICAL, INC.

49 records. Showing 1-40. Next

GUDID#

NxStage Dosing Calculator - NX1272
NXSTAGE MEDICAL, INC.
2015-09-01
NXSTAGE LEAK DETECTION SENSOR AND TRAY ACCESSORY KIT - NX0642
NXSTAGE MEDICAL, INC.
2015-09-01
NXSTAGE LEAK DETECTION SENSOR AND TRAY ACCESSORY KIT - NX1348
NXSTAGE MEDICAL, INC.
2015-09-01
NXSTAGE LEAK DETECTION SENSOR AND TRAY ACCESSORY KIT - NX1373
NXSTAGE MEDICAL, INC.
2015-09-01
EXPRESS FLUID WARMER - FW-300-WW
NXSTAGE MEDICAL, INC.
2015-09-01
VersiHD - NX1000-10-B
NXSTAGE MEDICAL, INC.
2021-12-08
NxStage PureFlow Solution - RFP-207-C
NXSTAGE MEDICAL, INC.
2026-06-22
NxStage PureFlow Solution - RFP-204-C
NXSTAGE MEDICAL, INC.
2026-06-22
NxStage PureFlow Solution - RFP-209-C
NXSTAGE MEDICAL, INC.
2026-06-22
EXPRESS FLUID WARMER - FW-300-WW
NXSTAGE MEDICAL, INC.
2026-04-29
System One Cycler Base - NxStage Leak Detection Sensor and Tray Accessory Kit
NXSTAGE MEDICAL, INC.
2026-04-22
Extended Cycler Base and Filter Holder - NxStage Leak Detection Sensor and Tray Accessory Kit
NXSTAGE MEDICAL, INC.
2026-04-22
Fluid Detection System - NxStage Leak Detection Sensor and Tray Accessory Kit
NXSTAGE MEDICAL, INC.
2026-04-22
VersiHD - NX1000-10-B
NXSTAGE MEDICAL, INC.
2026-04-22
VersiHD with GuideMe Software - NX1000-10-E
NXSTAGE MEDICAL, INC.
2025-09-23
VersiHD with GuideMe Software - NX1000-16-H
NXSTAGE MEDICAL, INC.
2025-09-23
VersiHD with GuideMe Software - NX1000-10-H
NXSTAGE MEDICAL, INC.
2025-09-23
VersiHD with GuideMe software - NX1000-10-E
NXSTAGE MEDICAL, INC.
2023-08-21
NxStage PureFlow Solution - RFP-205-WW
NXSTAGE MEDICAL, INC.
2015-09-01
NxStage PureFlow Solution - RFP-205-WW
NXSTAGE MEDICAL, INC.
2015-09-01
VersiHD with GuideMe software - NX1000-10-G
NXSTAGE MEDICAL, INC.
2024-01-25
VersiHD with GuideMe software - NX1000-10-F
NXSTAGE MEDICAL, INC.
2023-08-21
VersiHD with GuideMe software - NX1000-16-F
NXSTAGE MEDICAL, INC.
2023-08-21
NXSTAGE CARTRIDGE EXPRESS - CAR-170-E
NXSTAGE MEDICAL, INC.
2024-07-24
NXSTAGE CARTRIDGE EXPRESS - CAR-172-E
NXSTAGE MEDICAL, INC.
2024-07-24
NXSTAGE SYSTEM ONE - MOBILE STAND - NX0153
NXSTAGE MEDICAL, INC.
2024-07-05
NxStage PureFlow Solution - RFP-207-A
NXSTAGE MEDICAL, INC.
2024-03-27
NxStage PureFlow Solution - RFP-204-A
NXSTAGE MEDICAL, INC.
2024-03-27
NxStage PureFlow Solution - RFP-209-A
NXSTAGE MEDICAL, INC.
2024-03-27
NxStage PureFlow Solution - RFP-211-A
NXSTAGE MEDICAL, INC.
2024-03-27
NxStage PureFlow Solution - RFP-205-A
NXSTAGE MEDICAL, INC.
2024-03-27
NxStage PureFlow Solution - RFP-220-A
NXSTAGE MEDICAL, INC.
2024-03-27
NxStage PureFlow Solution - RFP-221-A
NXSTAGE MEDICAL, INC.
2024-03-27
NxStage PureFlow Solution - RFP-222-A
NXSTAGE MEDICAL, INC.
2024-03-27
NxStage PureFlow Solution - RFP-223-A
NXSTAGE MEDICAL, INC.
2024-03-27
NxStage PureFlow Solution - RFP-224-A
NXSTAGE MEDICAL, INC.
2024-03-27
NxStage PureFlow Solution - RFP-207-A
NXSTAGE MEDICAL, INC.
2024-03-27
NxStage PureFlow Solution - RFP-204-A
NXSTAGE MEDICAL, INC.
2024-03-27
NxStage PureFlow Solution - RFP-209-A
NXSTAGE MEDICAL, INC.
2024-03-27
NxStage PureFlow Solution - RFP-211-A
NXSTAGE MEDICAL, INC.
2024-03-27

200 records. Showing 1-40. Next