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WATERS CORPORATION

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
12189591218959WATERS CORPORATION1N2026-01-0134 MAPLE ST MILFORD MA US 01757
21237742123774WATERS MEDICAL SYSTEMS, LLC1Y2026-01-012900 37th St NW Building 003 ROCHESTER MN US 55901
30002219473000221947WATERS TECHNOLOGIES CORPORATION1N2026-01-01STAMFORD AVENUE, ALTRINCHAM ROAD WILMSLOW Manchester GB SK9 4AX
30175978683017597868Watershed Idea Foundry, Inc.1N2026-01-011815 Aston Ave., Suite 106 Carlsbad CA US 92008
14245253003000142WATERS INDUSTRIES, INC.1Y2020-04-25213 W. MAIN ST. Dundee IL US 60118

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 GUDIDProductPhoneEmail
00816776020247MassTrak - MassTrak Endocrine Blank Calibrator1-800-252-4752customerservice@waters.com
00816776020551MassTrak - MassTrak™ Steroid Serum QC Set 21-800-252-4752customerservice@waters.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
830461398193225K991594CELSIOR COLD FLUSH, STORAGE AND TRANSPORT SOLUTION FOR HEARTSMSB1999-08-05
830461845457735K971571RM3 RENAL PRESERVATION SYSTEM--CONTROL UNITKDN1997-07-29
830461557590702K921519OXICOM-2100DQA1992-10-23
830461414761650K911207OXICOMPLUSDQA1991-08-26
830461738214862K221387BEL-GEN Cold Storage SolutionKDL2022-06-14
830461721901989K221386PERF-GEN Pulsatile Perfusion SolutionKDL2022-06-14
830461401967044K211224RM4 Control UnitKDN2021-10-15
830462073597761K121736PERF-GEN PULSATILE PERFUSION SOLUTIONKDL2013-08-16
830462073682351K121618BEL-GEN COLD STORAGE SOLUTIONKDL2013-06-14
830461636720864K111521WAVESKDN2012-02-16
830461238833918K080432MAPERSOLKDN2008-08-08
830461231328734K073693COSTORSOLKDN2008-07-03
13421605862277K063868MASSTRAK IMMUNOSUPPRESSANTS KITMLM2007-05-25
830461173347417K053327OXICOM CONTROLJJX2006-01-26
1057271491234765
1057271813264506
2827201003037350
2827201044395313
13421047597007
2827201057723886
2827201070378783
2827201167664359
2827201179942795
2827201184644363
2827201185116393
2827201211538888
2827201212252786
2827201212651453
2827201213958625
13421231851539
2827201234527116
2827201244243373
2827201253322760
2827201297971305
2827201332079062
2827201371999380
2827201372801697
13421379001499
2827201389415148
13421426616957
2827201451110823
2827201588683422
2827201614145410
2827201619622166
2827201630056460
2827201638520109
2827201708959736
2827201727864322
2827201761888544
2827201795558929
2827201801450427
2827201802506833
2827201916312414
13401934478919
13421934478919
2827201938397535
2827201947411023
13421959371725
2827201965650236
2827201974216212
2827201978976884
2827202012184030

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
KDN52021-10-15
KDL42022-06-14
DQA21992-10-23
MLM12007-05-25
JJX12006-01-26
MSB11999-08-05

PMN#

WAVES

2012-02-16

WATERS MEDICAL SYSTEMS, LLC

OMNI-JUG

1995-06-29

WATERSTONE MEDICAL, INC.

GUDID#

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 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

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

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