Nxstage Medical Inc

FDA Filings

This page includes the latest FDA filings for Nxstage Medical Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3003464075
• FEI Number: 3003464075
• Name: NXSTAGE MEDICAL, INC.
• Owner & Operator: Fresenius Medical Care Holdings, Inc.
• Contact Address: 920 Winter Street ; Waltham MA 02451 US
• Official Correspondent:
  • Denise Oppermann
  • 01-781-6994479-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 350 Merrimack St ; LAWRENCE, MA 01843 US
• Establishment Type:
  • Complaint File Establishment per 21 CFR 820.198
  • Develop Specifications But Do Not Manufacture At This Facility

FDA Filings

Device Company	Device	Date
GUDID 10842289103136 NXSTAGE MEDICAL, INC.	NxStage PureFlow Solution	2024-04-04
GUDID 10842289103129 NXSTAGE MEDICAL, INC.	NxStage PureFlow Solution	2024-04-04
GUDID 10842289103112 NXSTAGE MEDICAL, INC.	NxStage PureFlow Solution	2024-04-04
GUDID 10842289103105 NXSTAGE MEDICAL, INC.	NxStage PureFlow Solution	2024-04-04
GUDID 10842289103099 NXSTAGE MEDICAL, INC.	NxStage PureFlow Solution	2024-04-04
GUDID 10842289103082 NXSTAGE MEDICAL, INC.	NxStage PureFlow Solution	2024-04-04
GUDID 10842289103075 NXSTAGE MEDICAL, INC.	NxStage PureFlow Solution	2024-04-04
GUDID 10842289103068 NXSTAGE MEDICAL, INC.	NxStage PureFlow Solution	2024-04-04
GUDID 10842289103051 NXSTAGE MEDICAL, INC.	NxStage PureFlow Solution	2024-04-04
GUDID 10842289103044 NXSTAGE MEDICAL, INC.	NxStage PureFlow Solution	2024-04-04
GUDID M535NX200010D0 NXSTAGE MEDICAL, INC.	PUREFLOW SL	2023-12-12
GUDID M535NX100010D0 NXSTAGE MEDICAL, INC.	VersiHD	2023-12-12
GUDID M535FW300D0 NXSTAGE MEDICAL, INC.	EXPRESS FLUID WARMER	2023-12-12
GUDID M535FWS3050 NXSTAGE MEDICAL, INC.	EXPRESS FLUID WARMER DISPOSABLE	2023-11-28
GUDID M535NX100016F0 NXSTAGE MEDICAL, INC.	VersiHD with GuideMe software	2023-08-29
GUDID M535NX100010F0 NXSTAGE MEDICAL, INC.	VersiHD with GuideMe software	2023-08-29
GUDID M535NX100010E0 NXSTAGE MEDICAL, INC.	VersiHD with GuideMe software	2023-08-29
GUDID M535NX200011A0 NXSTAGE MEDICAL, INC.	PUREFLOW SL	2023-06-29
GUDID M535CAR510B5 NXSTAGE MEDICAL, INC.	NXSTAGE TPE CARTRIDGE	2023-06-20
GUDID M535FW301A0 NXSTAGE MEDICAL, INC.	EXPRESS FLUID WARMER	2022-03-22
GUDID M535FW30110 NXSTAGE MEDICAL, INC.	EXPRESS FLUID WARMER ACCESSORIES	2022-03-22
GUDID M535FW3010 NXSTAGE MEDICAL, INC.	EXPRESS FLUID WARMER	2022-03-22
GUDID M535FW300WW0 NXSTAGE MEDICAL, INC.	EXPRESS FLUID WARMER	2022-03-22
GUDID M535FW300A0 NXSTAGE MEDICAL, INC.	EXPRESS FLUID WARMER	2022-03-22
GUDID M535FW30010 NXSTAGE MEDICAL, INC.	EXPRESS FLUID WARMER ACCESSORIES	2022-03-22
GUDID M535FW3000 NXSTAGE MEDICAL, INC.	EXPRESS FLUID WARMER	2022-03-22
GUDID M535FW2000 NXSTAGE MEDICAL, INC.	COMFORTMATE FLUID WARMER	2022-03-22
GUDID M535NX100010B0 NXSTAGE MEDICAL, INC.	VersiHD	2021-12-16
GUDID M535CAR5355 NXSTAGE MEDICAL, INC.	NXSTAGE CARTRIDGE EXPRESS WITH SPEEDSWAP	2021-09-17
GUDID M535NX1272 NXSTAGE MEDICAL, INC.	NxStage Dosing Calculator	2021-06-08
GUDID M535NX1225NX1380 NXSTAGE MEDICAL, INC.	Nx2me Connected Health Nx2me Clinician Portal	2021-06-08
GUDID M535NX1225NX1379 NXSTAGE MEDICAL, INC.	Nx2me Connected Health Nx2me App	2021-06-08
GUDID 10842289102603 NXSTAGE MEDICAL, INC.	Medic Anti-stick Needle/Connector	2020-10-20
GUDID 10842289102610 NXSTAGE MEDICAL, INC.	Dialysis Priming Set	2020-10-14
GUDID 00842289102361 NXSTAGE MEDICAL, INC.	masterguard plus HEMODIALYSIS FISTULA NEEDLE SET	2020-07-24
GUDID 10842289102863 NXSTAGE MEDICAL, INC.	masterguard plus HEMODIALYSIS FISTULA NEEDLE SET	2020-07-22
GUDID 10842289102856 NXSTAGE MEDICAL, INC.	masterguard plus HEMODIALYSIS FISTULA NEEDLE SET	2020-07-22
GUDID 00842289102453 NXSTAGE MEDICAL, INC.	masterguard plus HEMODIALYSIS FISTULA NEEDLE SET	2020-07-16
GUDID 00842289102446 NXSTAGE MEDICAL, INC.	masterguard plus HEMODIALYSIS FISTULA NEEDLE SET	2020-07-16
GUDID 00842289102439 NXSTAGE MEDICAL, INC.	masterguard plus HEMODIALYSIS FISTULA NEEDLE SET	2020-07-16
GUDID 00842289102422 NXSTAGE MEDICAL, INC.	masterguard plus HEMODIALYSIS FISTULA NEEDLE SET	2020-07-16
GUDID 00842289102415 NXSTAGE MEDICAL, INC.	masterguard plus HEMODIALYSIS FISTULA NEEDLE SET	2020-07-16
GUDID 00842289102408 NXSTAGE MEDICAL, INC.	masterguard plus HEMODIALYSIS FISTULA NEEDLE SET	2020-07-16
GUDID 00842289102392 NXSTAGE MEDICAL, INC.	masterguard plus HEMODIALYSIS FISTULA NEEDLE SET	2020-07-16
GUDID 00842289102378 NXSTAGE MEDICAL, INC.	masterguard plus HEMODIALYSIS FISTULA NEEDLE SET	2020-07-16
GUDID 00842289102286 NXSTAGE MEDICAL, INC.	masterguard plus TWINPACK+ HEMODIALYSIS FISTULA NEEDLE SETS	2020-07-16
GUDID 00842289102279 NXSTAGE MEDICAL, INC.	masterguard plus TWINPACK+ HEMODIALYSIS FISTULA NEEDLE SETS	2020-07-16
GUDID 00842289102262 NXSTAGE MEDICAL, INC.	masterguard plus TWINPACK+ HEMODIALYSIS FISTULA NEEDLE SETS	2020-07-16
GUDID 00842289102255 NXSTAGE MEDICAL, INC.	masterguard plus TWINPACK+ HEMODIALYSIS FISTULA NEEDLE SETS	2020-07-16
GUDID 00842289102248 NXSTAGE MEDICAL, INC.	masterguard plus TWINPACK+ HEMODIALYSIS FISTULA NEEDLE SETS	2020-07-16
GUDID 00842289102231 NXSTAGE MEDICAL, INC.	masterguard plus TWINPACK+ HEMODIALYSIS FISTULA NEEDLE SETS	2020-07-16
GUDID 00842289102224 NXSTAGE MEDICAL, INC.	masterguard plus TWINPACK+ HEMODIALYSIS FISTULA NEEDLE SETS	2020-07-16
GUDID 00842289102217 NXSTAGE MEDICAL, INC.	masterguard plus TWINPACK+ HEMODIALYSIS FISTULA NEEDLE SETS	2020-07-16
GUDID 00842289102200 NXSTAGE MEDICAL, INC.	masterguard plus TWINPACK+ HEMODIALYSIS FISTULA NEEDLE SETS	2020-07-16
GUDID 00842289102194 NXSTAGE MEDICAL, INC.	masterguard plus TWINPACK+ HEMODIALYSIS FISTULA NEEDLE SETS	2020-07-16
GUDID 00842289102187 NXSTAGE MEDICAL, INC.	masterguard plus TWINPACK+ HEMODIALYSIS FISTULA NEEDLE SETS	2020-07-16
GUDID 00842289102170 NXSTAGE MEDICAL, INC.	masterguard plus TWINPACK+ HEMODIALYSIS FISTULA NEEDLE SETS	2020-07-16
GUDID 00842289102163 NXSTAGE MEDICAL, INC.	masterguard plus TWINPACK+ HEMODIALYSIS FISTULA NEEDLE SETS	2020-07-16
GUDID 00842289102156 NXSTAGE MEDICAL, INC.	masterguard plus TWINPACK+ HEMODIALYSIS FISTULA NEEDLE SETS	2020-07-16
GUDID 00842289102149 NXSTAGE MEDICAL, INC.	masterguard plus TWINPACK+ HEMODIALYSIS FISTULA NEEDLE SETS	2020-07-16
GUDID 00842289102132 NXSTAGE MEDICAL, INC.	masterguard plus TWINPACK+ HEMODIALYSIS FISTULA NEEDLE SETS	2020-07-16
GUDID 00842289102101 NXSTAGE MEDICAL, INC.	masterguard plus TWINPACK+ HEMODIALYSIS FISTULA NEEDLE SETS	2020-07-16
GUDID 00842289102095 NXSTAGE MEDICAL, INC.	masterguard plus TWINPACK+ HEMODIALYSIS FISTULA NEEDLE SETS	2020-07-16
GUDID 10842289102993 NXSTAGE MEDICAL, INC.	ButtonHole SINGLE NEEDLE SET	2020-07-14
GUDID 10842289102733 NXSTAGE MEDICAL, INC.	masterguard APHERESIS NEEDLE	2020-07-14
GUDID 10842289102719 NXSTAGE MEDICAL, INC.	masterguard APHERESIS NEEDLE	2020-07-14
GUDID 10842289102702 NXSTAGE MEDICAL, INC.	masterguard APHERESIS NEEDLE	2020-07-14
GUDID 10842289102696 NXSTAGE MEDICAL, INC.	masterguard APHERESIS NEEDLE	2020-07-14
GUDID 10842289102689 NXSTAGE MEDICAL, INC.	masterguard APHERESIS NEEDLE	2020-07-14
GUDID 10842289102672 NXSTAGE MEDICAL, INC.	masterguard APHERESIS NEEDLE	2020-07-14
GUDID 10842289102665 NXSTAGE MEDICAL, INC.	masterguard APHERESIS NEEDLE	2020-07-14
GUDID 10842289102641 NXSTAGE MEDICAL, INC.	NxStage SINGLE NEEDLE FISTULA SET	2020-07-14
GUDID 10842289102597 NXSTAGE MEDICAL, INC.	NxStage SINGLE NEEDLE FISTULA SET	2020-07-14
GUDID 10842289102467 NXSTAGE MEDICAL, INC.	ButtonHole SINGLE NEEDLE SET	2020-07-14
GUDID 10842289102580 NXSTAGE MEDICAL, INC.	ButtonHole NEEDLE SET	2020-07-07
GUDID 10842289102573 NXSTAGE MEDICAL, INC.	ButtonHole NEEDLE SET	2020-07-07
GUDID 10842289102566 NXSTAGE MEDICAL, INC.	ButtonHole with SteriPick NEEDLE SET	2020-07-07
GUDID 10842289102559 NXSTAGE MEDICAL, INC.	ButtonHole with SteriPick NEEDLE SET	2020-07-07
GUDID 10842289102542 NXSTAGE MEDICAL, INC.	ButtonHole NEEDLE SET	2020-07-07
GUDID 10842289102535 NXSTAGE MEDICAL, INC.	ButtonHole NEEDLE SET	2020-07-07
GUDID 10842289102528 NXSTAGE MEDICAL, INC.	ButtonHole NEEDLE SET	2020-07-07
GUDID 10842289102511 NXSTAGE MEDICAL, INC.	ButtonHole with SteriPick NEEDLE SET	2020-07-07
GUDID 10842289102504 NXSTAGE MEDICAL, INC.	ButtonHole with SteriPick NEEDLE SET	2020-07-07
GUDID 10842289102498 NXSTAGE MEDICAL, INC.	ButtonHole with SteriPick NEEDLE SET	2020-07-07
GUDID 10842289102481 NXSTAGE MEDICAL, INC.	ButtonHole with SteriPick NEEDLE SET	2020-07-07
GUDID 10842289102474 NXSTAGE MEDICAL, INC.	ButtonHole with SteriPick NEEDLE SET	2020-07-07
GUDID 00842289102309 NXSTAGE MEDICAL, INC.	ButtonHole with SteriPick NEEDLE SET	2020-07-02
GUDID 00842289102293 NXSTAGE MEDICAL, INC.	ButtonHole with SteriPick NEEDLE SET	2020-07-02
GUDID 00842289102088 NXSTAGE MEDICAL, INC.	ButtonHole with SteriPick TWINPACK+ NEEDLE SET	2020-07-02
GUDID 00842289102071 NXSTAGE MEDICAL, INC.	ButtonHole with SteriPick TWINPACK+ NEEDLE SET	2020-07-02
GUDID 00842289102064 NXSTAGE MEDICAL, INC.	ButtonHole with SteriPick TWINPACK+ NEEDLE SET	2020-07-02
GUDID 00842289102057 NXSTAGE MEDICAL, INC.	ButtonHole with SteriPick TWINPACK+ NEEDLE SET	2020-07-02
GUDID 00842289102040 NXSTAGE MEDICAL, INC.	ButtonHole with SteriPick TWINPACK+ NEEDLE SET	2020-07-02
GUDID 00842289102033 NXSTAGE MEDICAL, INC.	ButtonHole with SteriPick TWINPACK+ NEEDLE SET	2020-07-02
GUDID 00842289102026 NXSTAGE MEDICAL, INC.	ButtonHole with SteriPick TWINPACK+ NEEDLE SET	2020-07-02
GUDID 00842289102019 NXSTAGE MEDICAL, INC.	ButtonHole with SteriPick TWINPACK+ NEEDLE SET	2020-07-02
GUDID 00842289102002 NXSTAGE MEDICAL, INC.	ButtonHole with SteriPick TWINPACK+ NEEDLE SET	2020-07-02
GUDID 00842289101999 NXSTAGE MEDICAL, INC.	ButtonHole with SteriPick TWINPACK+ NEEDLE SET	2020-07-02
GUDID 00842289101982 NXSTAGE MEDICAL, INC.	ButtonHole with SteriPick TWINPACK+ NEEDLE SET	2020-07-02
GUDID 00842289101975 NXSTAGE MEDICAL, INC.	ButtonHole with SteriPick TWINPACK+ NEEDLE SET	2020-07-02
KDI NXSTAGE MEDICAL, INC. [Fresenius Medical Care Holdings, Inc.]	NxStage Cartridge with Infusion Line	2019-10-29
PMN K983076 | FIB NXSTAGE MEDICAL, INC. [Fresenius Medical Care Holdings, Inc.]	ViraGuard Viral Blocking Patient Transducer Protector	2019-09-25
PMN K133547 | KDI NXSTAGE MEDICAL, INC. [Fresenius Medical Care Holdings, Inc.]	NxStage Cartridge Express	2019-09-25
PMN K183158 NxStage Medical, Inc.	NxStage Cartridge Express With Speedswap	2019-08-09
PMN K181991 NxStage Medical, Inc	NxStage Connected Health System	2018-09-26
PMN K171331 NxStage Medical, Inc.	NxStage System One	2017-08-24
PMN K170469 NxStage Medical, Inc	NxStage System One Plus	2017-05-09
PMN K150472 NXSTAGE MEDICAL, INC.	NxStage System One	2015-06-04
PMN K143313 NxStage Medical, Inc.	NxStage Therapeutic Plasma Exchange (TPE) Cartridge	2015-03-20
PMN K141752 NXSTAGE MEDICAL, INC.	NXSTAGE SYSTEM ONE	2014-12-19
PMN K134019 NXSTAGE MEDICAL, INC.	MEDISYSTEMS ONESITE DUAL LUMEN NEEDLE WITH MASTERGUARD ANTI-STICK NEEDLE PROTECTOR, MEDISYSTEMS ONESITE DUAL LUMEN BUTTO	2014-09-11
PMN K140623 NXSTAGE MEDICAL, INC.	NXSTAGE EXPRESS FLUID WARMER	2014-06-16
PMN K140526 NXSTAGE MEDICAL, INC.	NXSTAGE SYSTEM ONE	2014-05-19
PMN K140571 NXSTAGE MEDICAL, INC.	NXSTAGE PUREFLOW SL	2014-05-15
PMN K133547 NXSTAGE MEDICAL, INC.	NXSTAGE SYSTEM ONE WITH NXVIEW	2014-03-03
PMN K132602 NXSTAGE MEDICAL, INC.	STREAMLINE EXPRESS	2014-02-04
PMN K131050 NXSTAGE MEDICAL, INC.	NXSTAGE 1.6M2 DIALYZER	2013-12-27
PMN K131739 NXSTAGE MEDICAL, INC.	NXSTAGE CONNECTED HEALTH SYSTEM	2013-10-10
PMN K130460 NXSTAGE MEDICAL, INC.	NXSTAGE DOSING CALCULATOR	2013-07-11
PMN K122051 NXSTAGE MEDICAL, INC.	NXSTAGE SYSTEM ONE	2013-04-23
PMN K123395 NXSTAGE MEDICAL, INC.	NXSTAGE SYSTEM ONE LOW VOLUME CARTRIDGE EXPRESS	2013-03-07
PMN K113023 NXSTAGE MEDICAL, INC.	STREAMLINE AIRLESS SYSTEM SET WITH PRE-ATTACHED DIALYZER	2012-12-21
PMN K111174 NXSTAGE MEDICAL, INC.	NXSTAGE PUREFLOW SL	2011-09-19
PMN K093069 NXSTAGE MEDICAL, INC.	NXSTAGE SYSTEM ONE WITH THERAPEUTIC PLASMA EXCHANGE CARTRIDGE	2010-10-23
PMN K090255 NXSTAGE MEDICAL, INC.	BLOOD TUBING SETS (STERILE FLUID PATH)	2009-02-10
PMN K080919 NXSTAGE MEDICAL, INC.	NXSTAGE PUREFLOW SL	2008-10-15
PMN K080807 NXSTAGE MEDICAL, INC.	BLOOD TUBING SETS (STERILE FLUID PATH)	2008-07-18
PMN K081043 NXSTAGE MEDICAL, INC.	LEAK DETECTION SENSOR AND TRAY ACCESSORY KIT	2008-07-07
PMN K071263 NXSTAGE MEDICAL, INC.	NXSTAGE TRAVEL WARMER, MODELS TW-400 & FWS-500	2007-08-24
PMN K061837 NXSTAGE MEDICAL, INC.	NXSTAGE CARTRIDGE EXPRESS	2006-07-31
PMN K060296 NXSTAGE MEDICAL, INC.	NXSTAGE DIALYSATE PREPARATION MODULE	2006-03-31
PMN K053286 NXSTAGE MEDICAL, INC.	MODIFICATION TO: NXSTAGE PUREFLOW-B SOLUTION	2005-12-22
PMN K050525 NXSTAGE MEDICAL, INC.	NXSTAGE SYSTEM ONE	2005-06-24
PMN K050727 NXSTAGE MEDICAL, INC.	MODIFICATION TO NXSTAGE CARTRIDGE EXPRESS	2005-06-13
PMN K043436 NXSTAGE MEDICAL, INC.	NXSTAGE DIALYSATE PREPARATION MODULE, MODEL NX0269	2005-03-17
PMN K042045 NXSTAGE MEDICAL, INC.	NXSTAGE PUREFLOW-B SOLUTION	2004-08-27
PMN K041424 NXSTAGE MEDICAL, INC.	NXSTAGE SYSTEM ONE	2004-07-02
PMN K040696 NXSTAGE MEDICAL, INC.	MODIFICATION TO NXSTAGE SYSTEM ONE	2004-05-26
PMN K040074 NXSTAGE MEDICAL, INC.	ONEVIEW INTERFACE	2004-04-08
PMN K033386 NXSTAGE MEDICAL, INC.	NXSTAGE PUREFLOW SOLUTION	2003-11-26
PMN K032356 NXSTAGE MEDICAL, INC.	NXSTAGE SYSTEM ONE WITH CARTRIDGE EXPRESS	2003-10-28
PMN K030470 NXSTAGE MEDICAL, INC.	NXSTAGE SYSTEM ONE	2003-07-07
PMN K014152 NXSTAGE MEDICAL, INC.	NXSTAGE CARTRIDGE EXPRESS	2002-12-11
PMN K022913 NXSTAGE MEDICAL, INC.	NXSTAGE PREMIXED DIALYSATE	2002-10-21
PMN K011269 NXSTAGE MEDICAL, INC.	LIFEMATE MLA MULTI-LINE ADAPTOR; LIFEMATE SFR STERILE FLUID RESERVOIR	2002-03-04
PMN K013655 NXSTAGE MEDICAL, INC.	NXSTAGE DIALYSATE CONCENTRATE, MODEL RFC-100	2002-02-04
PMN K012832 NXSTAGE MEDICAL, INC.	COMFORTMATE FLUID WARMING SYSTEM, MODEL # FW-200; COMFORTMATE DISPORSABLE DISPOSABLE WARMING SET, MODEL #FWS-200	2001-10-24
PMN K012510 NXSTAGE MEDICAL, INC.	MODIFICATION TO: LIFEMATE HEMOFILTRATION SYSTEM	2001-10-19
PMN K001283 NXSTAGE MEDICAL, INC.	LIFEMATE HEMOFILTRATION SYSTEM	2001-01-17

Related Finance Registrations

NCAGE Code	4ELZ9	NXSTAGE MEDICAL, INC.
CAGE Code	4ELZ9	NXSTAGE MEDICAL, INC. NXSTAGE
S.A.M. Registration	4ELZ9 [88013219]	NXSTAGE MEDICAL, INC.
SEC	0001106687	NXSTAGE MEDICAL INC
SEC	0001333170	NxStage Medical, Inc. of DELAWARE