WATERS MEDICAL SYSTEMS, LLC

Address:2112 15TH ST NW,ROCHESTER,MN,55901,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

System, Perfusion, Kidney (KDN) (8) Oximeter (DQA) (1)

Premarket Exempt

Clear

Oxicom 2100 Box Kit - B154OXIKIT21003 Catalog Number : 0007290.000

Device Description : Oxicom 2100 Box containing 100ct cuvette/plugs & QC 1,2,3 sticks

Device Class :

Duns Number: 556957871

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

Oxicom 3000 Box Kit - B154OXIKIT30003 Catalog Number : 0006790.000

Device Description : Oxicom 3000 Box Kit containing 100ct cuvette/plugs & QC 1,2,3 sticks

Device Class : 2

Duns Number: 556957871

Premarket Exempt : No

Product Code : DQA

Prescription Use : No

Device Count : 1

MOX/RM3 Battery - B154R00060040000 Catalog Number : 0006004.000

Device Description : Replacement battery for use in the MOX/RM3 control unit.

Device Class : 2

Duns Number: 556957871

Premarket Exempt : No

Product Code : KDN

Prescription Use : No

Device Count : 1

INSULATED CASSETTE COVER DCM - B154R00081290000 Catalog Number : 0008129.000

Device Description : INSULATED CASSETTE COVER DCM

Device Class : 2

Duns Number: 556957871

Premarket Exempt : No

Product Code : KDN

Prescription Use : No

Device Count : 1

DCM-100 DUAL KIDNEY CASSETTE - B154R00126910000 Catalog Number : 0012691.000

Device Description : The cassette is a self-contained circulation system consisting of an organ chamb 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 or two kidneys. The kidneys are attached to the arterial ports either in single fashion, or can be placed enbloc.

Device Class :

Duns Number: 556957871

Premarket Exempt : No

Product Code : KDN

Prescription Use : No

Device Count : 1

DCM100 Training Cassette - Non Sterile - B154R00126910050 Catalog Number : 0012691.005

Device Description : DCM100 Training Cassette - Non Sterile

Device Class : 2

Duns Number: 556957871

Premarket Exempt : No

Product Code : KDN

Prescription Use : No

Device Count : 1

TA100 TRIPLE ARTERY CANNULA - Sterile - 1/packaging - B154R00150930010 Catalog Number : 0015093.001

Device Description : TA100 TRIPLE ARTERY CANNULA - Sterile - 1/packaging

Device Class : 2

Duns Number: 556957871

Premarket Exempt : No

Product Code : KDN

Prescription Use : No

Device Count : 1

RM3 Accessory Filter - B154R31800030050 Catalog Number : 3900056.001

Device Description : RM3 Accessory Filter

Device Class : 2

Duns Number: 556957871

Premarket Exempt : No

Product Code : KDN

Prescription Use : No

Device Count : 1

RM3 Accessory - Adapter - B154R32000910050 Catalog Number : 3200091.005

Device Description : RM3 Accessory - Filter Adapter

Device Class : 2

Duns Number: 556957871

Premarket Exempt : No

Product Code : KDN

Prescription Use : No

Device Count : 1

RM3 RENAL PERFUSION MONITOR - B154R39000400040 Catalog Number : 3900040.004

Device Description : RM3 RENAL PERFUSION MONITOR

Device Class : 2

Duns Number: 556957871

Premarket Exempt : No

Product Code : KDN

Prescription Use : No

Device Count : 1

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