WATERS CORPORATION

FDA Registration(s)#

GUDID Contact Samples#

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

• waters.com

Registered Device Listings#

Product Codes Associated With Registrations#

PMN#

• PERF-GEN PULSATILE PERFUSION SOLUTION

  2013-08-16

  WATERS MEDICAL SYSTEMS, LLC

• BEL-GEN COLD STORAGE SOLUTION

  2013-06-14

  WATERS MEDICAL SYSTEMS, LLC

• WAVES

  2012-02-16

  WATERS MEDICAL SYSTEMS, LLC

• MASSTRAK IMMUNOSUPPRESSANTS KIT

  2007-05-25

  WATERS CORPORATION

• RM3 RENAL PRESERVATION SYSTEM

  2006-01-17

  WATERS INSTRUMENTS, INC.

• RM3 RENAL PRESERVATION SYSTEM

  2004-10-22

  WATERS INSTRUMENTS, INC.

• 2700 SAMPLE MANAGER

  1998-02-12

  WATERS CORPORATION

• 2487 DUAL WAVELENGTH ABSORBANCE DETECTOR

  1997-10-06

  WATERS CORPORATION

• RM3 RENAL PRESERVATION SYSTEM--CONTROL UNIT

  1997-07-29

  WATERS INSTRUMENTS, INC.

• WATERS 515 HPLC PUMP (515)

  1996-11-29

  WATERS CORPORATION

• WATERS 474 SCANNING FLOURESCENCE DETECTOR (474)

  1996-07-22

  WATERS CORPORATION

• ALLIANCE 2690 SEPARATIONS MODULE

  1996-07-05

  WATERS CORPORATION

• OMNI-JUG

  1995-06-29

  WATERSTONE MEDICAL, INC.

• WATERS PICO TAG CHEM PACK/FREE AMINO ACID ANALYSIS

  1995-05-02

  WATERS CHROMATOGRAPHY DIVISION

• OXICOM-2100

  1992-10-23

  WATERS INSTRUMENTS, INC.

• OXICOMPLUS

  1991-08-26

  WATERS INSTRUMENTS, INC.

• HIGH PRESSURE INERT PLASTIC COLUMNS FOR CLIN. USE

  1989-10-06

  WATERS CHEMICAL PRODUCTS

• ADVANCED PURIFICATION GLASS COLUMN

  1989-04-26

  WATERS CHEMICAL PRODUCTS

• VELCOM-100

  1986-11-26

  WATERS INSTRUMENTS, INC.

• OSC-80 OXIMETER

  1986-08-18

  WATERS INSTRUMENTS, INC.

• MVP - 6000

  1985-11-14

  WATERS INSTRUMENTS, INC.

• TX-2 THERMAL DILUTION CARDIAC OUTPUT

  1984-08-23

  WATERS INSTRUMENTS, INC.

• POLYURETHANE THERMAL DILUTION CATHET

  1984-07-13

  WATERS INSTRUMENTS, INC.

• WATERS ILEOSTOMY VALVE

  1982-04-09

  WATERS INSTRUMENTS, INC.

• WATERS ILEAL RESERVOIR CATHETER

  1981-12-31

  WATERS INSTRUMENTS, INC.

• MODEL 480 VARIABLE WAVELENGTH ULTRA VIOL

  1981-07-27

  WATERS ASSOC., INC.

• 7FRENCH FLOW DIRECTED TRIPLE LUMEN CATH

  1980-10-31

  WATERS ASSOC., INC.

• MRM-2 OXYGEN CONSUMPTION MONITOR

  1980-08-20

  WATERS ASSOC., INC.

• PAN-AM MYELOGRAM TRAY

  1980-08-12

  WATERS ASSOC., INC.

• SYSTEM CONTROLLER 720 SERIES

  1979-09-24

  WATERS ASSOC., INC.

• 4F STERILE BALLOON-LESS, CATHETER 913-28

  1979-06-22

  WATERS ASSOC., INC.

• CARTRIDGE HOLDER, RCM 100

  1979-02-15

  WATERS ASSOC., INC.

• SOLVENT DELIVERY SYSTEM

  1979-02-15

  WATERS ASSOC., INC.

• CARDIAC COMPUTERS, CO-10 & CO-10R

  1979-01-29

  WATERS ASSOC., INC.

• DATA MODULE

  1979-01-10

  WATERS ASSOC., INC.

• CALIBRATOR, DYNAMIC

  1978-11-29

  WATERS ASSOC., INC.

• PAB CONVENIENCE TRAY

  1978-09-20

  WATERS ASSOC., INC.

• RECORDER, RE-100P HOT STYLUS STRIP CHART

  1978-03-27

  WATERS ASSOC., INC.

• FLUORESCENCE DETECTOR MODEL 420

  1978-01-20

  WATERS ASSOC., INC.

• WISP MODEL 710

  1978-01-12

  WATERS ASSOC., INC.

GUDID#

• Xevo - Xevo TQ Absolute XR IVD

  WATERS TECHNOLOGIES CORPORATION

  2026-07-07

• MassTrak - MassTrak™ Steroid Serum QC Set 2

  WATERS TECHNOLOGIES CORPORATION

  2023-12-05

• WCM Cassette (included in WCM cassettes kit) - 1/sterile bag - The cassette is a self-contained circulation system consisting of an organ chamber, a venous and arterial reservoir, a bubble trap, a membrane oxygenator, a heat exchanger and pulsatile pump head. The system can provide circulation of one liter of PPS (machine perfusate) to one kidney. The kidney is attached to the arterial ports either in single fashion, or can be placed enbloc.

  WATERS MEDICAL SYSTEMS, LLC

  2017-02-12

• WAVES Specimen Tube - Tubes for specimen collection.

  WATERS MEDICAL SYSTEMS, LLC

  2017-02-12

• RM3 RENAL PERFUSION MONITOR - RM3

  WATERS MEDICAL SYSTEMS, LLC

  2017-01-23

• WCM Kit - DESCRIPTION The Waters WCM is primarily made of polycarbonate plastic. The pre-sterilized cassette contains a complete circulatory system (refer to diagram), designed for use on the Waters WAVES control unit. HOW SUPPLIED: The Waters WCM cassette is wrapped in a sterile wrap, sealed in a polyethylene bag, and is provided STERILE (ethylene oxide) fluid pathway. The Waters WCM cassette is intended for single-use only. CONTENTS: One (1) STERILE Waters WCM disposable cassette. One (1) STERILE Drape.Five (5) STERILE Specimen Tubes

  WATERS MEDICAL SYSTEMS, LLC

  2017-02-12

• WAVES/WCM Sterile Drape - Sterile WCM drape. For use with WAVES/WCM perfusion control unit.

  WATERS MEDICAL SYSTEMS, LLC

  2017-02-12

• MassTrak - MassTrak Endocrine Blank Calibrator

  WATERS TECHNOLOGIES CORPORATION

  2022-12-22

• WAVES Transport Bag - Transport bag specifically designed to accommodate a running WAVES unit to allow easier handling for transplant activities.

  WATERS MEDICAL SYSTEMS, LLC

  2017-02-12

• WCM Training Cassette - Non Sterile - WCM

  WATERS MEDICAL SYSTEMS, LLC

  2018-04-04

• WAVES CONTROL UNIT - The WAVES “single kidney” machine perfusion device is a three-part system composed of a control unit, a disposable “WCM” cassette, and remote monitoring software. WMS designed the device with an ice/water backup system along with battery back-up power. These systems allow for transport or remote monitoring if customers decide this is necessary. Donor paperwork and typing materials, biopsy slides, and other specimens can be transported securely with the kidney using the system. The system provides optimal preservation while increasing the user’s ability to assess parameters. Our goal is to assist the OPO and transplant center by improving DGF rates and patient outcomes following transplantation.

  WATERS MEDICAL SYSTEMS, LLC

  2017-02-12

• RM3 Tool Kit

  WATERS MEDICAL SYSTEMS, LLC

  2017-03-27

• Oxicom 3000 Box Kit - Oxicom 3000 Box Kit containing 100ct cuvette/plugs & QC 1,2,3 sticks

  WATERS MEDICAL SYSTEMS, LLC

  2017-02-12

• Oxicom 2100 Box Kit - Oxicom 2100 Box containing 100ct cuvette/plugs & QC 1,2,3 sticks

  WATERS MEDICAL SYSTEMS, LLC

  2017-02-12

• Oxicom 2100 Oximeter - Our Oxicom whole blood oximeter provides cardiologists and surgeons with critical information of patient oxygen saturation; this device is a vital part of any cardiac catheterization laboratory and surgical center. The Waters Oxicom is used to measure over 500,000 patient blood samples annually. An easy-to-use, whole blood oximeter to measure O2 saturation in whole blood.

  WATERS MEDICAL SYSTEMS, LLC

  2017-02-12

• Oxicom 3000 Oximeter - Our Oxicom whole blood oximeter provides cardiologists and surgeons with critical information of patient oxygen saturation; this device is a vital part of any cardiac catheterization laboratory and surgical center. The Waters Oxicom is used to measure over 500,000 patient blood samples annually. OXICOM 3000 WHOLE BLOOD OXIMETER. An easy-to-use, whole blood oximeter to measure O2 saturation in whole blood and calculate the arterial and venous content difference (AVO2).

  WATERS MEDICAL SYSTEMS, LLC

  2017-02-12

• MassTrak - MassTrak™ Steroid Internal Standard Mix

  WATERS TECHNOLOGIES CORPORATION

  2023-12-05

• MassTrak - MassTrak™ Steroid Optimization Mix

  WATERS TECHNOLOGIES CORPORATION

  2023-12-05

• MassTrak - MassTrak™ Steroid Serum QC Set 3

  WATERS TECHNOLOGIES CORPORATION

  2023-12-05

• MassTrak - MassTrak™ Steroid Serum Cal Set 3

  WATERS TECHNOLOGIES CORPORATION

  2023-12-05

• MassTrak - MassTrak™ Steroid Serum Cal Set 2

  WATERS TECHNOLOGIES CORPORATION

  2023-12-05

• Xevo - 186009782IVD

  WATERS TECHNOLOGIES CORPORATION

  2023-04-06

• MassTrak - MassTrak™ Endocrine Steroid Quality Control Set

  WATERS TECHNOLOGIES CORPORATION

  2021-10-25

• MassTrak - MassTrak™ Endocrine Steroid Calibrator Set

  WATERS TECHNOLOGIES CORPORATION

  2021-10-25

• Acquity - ACQUITY UPLC Autosampler Mod., IVD

  WATERS TECHNOLOGIES CORPORATION

  2021-10-01

• Acquity - ACQUITY UPLC Binary Solvent Mgr., IVD

  WATERS TECHNOLOGIES CORPORATION

  2021-10-01

• Acquity - ACQUITY UPLC I-Class SM-FTN, IVD

  WATERS TECHNOLOGIES CORPORATION

  2021-10-01

• Acquity - ACQUITY UPLC I-Class CH-A, IVD

  WATERS TECHNOLOGIES CORPORATION

  2021-10-01

• Acquity - ACQUITY UPLC I-Class BSM, IVD

  WATERS TECHNOLOGIES CORPORATION

  2021-10-01

• Xevo - Xevo TQD IVD

  WATERS TECHNOLOGIES CORPORATION

  2021-10-04

• Xevo - Xevo TQ-S, IVD

  WATERS TECHNOLOGIES CORPORATION

  2021-10-04

• Acquity - ACQUITY UPLC Column Manager-A (CM-A), IVD)

  WATERS TECHNOLOGIES CORPORATION

  2021-10-04

• Acquity - ACQUITY UPLC Sample Organizer, IVD

  WATERS TECHNOLOGIES CORPORATION

  2021-10-04

• WCM Kit - DESCRIPTION The Waters WCM is primarily made of polycarbonate plastic. The pre-sterilized cassette contains a complete circulatory system (

  WATERS MEDICAL SYSTEMS, LLC

  2017-02-12

• WAVES/WCM Sterile Drape - Sterile WCM drape. For use with WAVES/WCM perfusion control unit.

  WATERS MEDICAL SYSTEMS, LLC

  2017-02-12

• Arterial Perfusion Occlusion Clamp - Arterial Perfusion Occlusion Clamp - 2ct/pkg

  WATERS MEDICAL SYSTEMS, LLC

  2017-02-12

• Trident Cannula - RM3 Accessory Trident Cannula

  WATERS MEDICAL SYSTEMS, LLC

  2017-02-12

• Cannula 14mm SS, Non-Sterile - Cannula 14mm Stainless Steel, Non-Sterile

  WATERS MEDICAL SYSTEMS, LLC

  2018-05-02

• Cannula 13mm SS, Non-Sterile - Cannula 13mm Stainless Steel, Non-Sterile

  WATERS MEDICAL SYSTEMS, LLC

  2018-05-02

• Cannula 12mm SS, Non-Sterile - Cannula 12mm Stainless Steel, Non-Sterile

  WATERS MEDICAL SYSTEMS, LLC

  2018-05-02

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