WATERS MEDICAL SYSTEMS, LLC

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

Want to know more about this Organization? Request more information now!

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

Oximeter (DQA) (9) System, Perfusion, Kidney (KDN) (1)

Premarket Exempt

Clear

RM3 Filter - B15431800030050 Catalog Number : 3180003.005

Device Description : RM3 Accessory - Filter

Device Class : 2

Duns Number: 556957871

Premarket Exempt : No

Product Code : KDN

Prescription Use : No

Device Count : 1

Oxicom 3000 Oximeter - B154O00067900000 Catalog Number : 0006790.000

Device Description : Our Oxicom whole blood oximeter provides cardiologists and surgeons with critica

Device Class : 2

Duns Number: 556957871

Premarket Exempt : No

Product Code : DQA

Prescription Use : No

Device Count : 1

Oxicom 2100 Oximeter - B154O00072900000 Catalog Number : 0007290.000

Device Description : Our Oxicom whole blood oximeter provides cardiologists and surgeons with critica

Device Class : 2

Duns Number: 556957871

Premarket Exempt : No

Product Code : DQA

Prescription Use : No

Device Count : 1

CUVETTES DC-80 Box 100 cuvettes & 100 plugs - B154O00103910003 Catalog Number : 0010391.000

Device Description : Box containing 100 cuvettes and 100 cuvette plugs for use with Oxicom oximeter.

Device Class :

Duns Number: 556957871

Premarket Exempt : No

Product Code : DQA

Prescription Use : No

Device Count : 1

CUVETTES DC-80 Box 100 cuvettes - B154O0010391CUVEACH00 Catalog Number : 0010391.000

Device Description : Disposable cuvettes for use with the Oxicom oximeter.

Device Class : 2

Duns Number: 556957871

Premarket Exempt : No

Product Code : DQA

Prescription Use : No

Device Count : 1

CONTROL LIQUID, OXICOM, BOX - B154O00340910000 Catalog Number : 0034091.000

Device Description : Weekly use of liquid controls are important for calibration verification of the

Device Class : 2

Duns Number: 556957871

Premarket Exempt : No

Product Code : DQA

Prescription Use : No

Device Count : 1

CONTROL LIQUID, OXICOM - High vial - B154O0034091HIG00 Catalog Number : 0034091.000

Device Description : Weekly use of liquid controls are important for calibration verification of the

Device Class : 2

Duns Number: 556957871

Premarket Exempt : No

Product Code : DQA

Prescription Use : No

Device Count : 1

CONTROL LIQUID, OXICOM - Low vial - B154O0034091LOW00 Catalog Number : 0034091.000

Device Description : Weekly use of liquid controls are important for calibration verification of the

Device Class : 2

Duns Number: 556957871

Premarket Exempt : No

Product Code : DQA

Prescription Use : No

Device Count : 1

CONTROL LIQUID, OXICOM - Medium vial - B154O0034091MED00 Catalog Number : 0034091.000

Device Description : Weekly use of liquid controls are important for calibration verification of the

Device Class : 2

Duns Number: 556957871

Premarket Exempt : No

Product Code : DQA

Prescription Use : No

Device Count : 1

CUVETTES DC-80 Box 100 cuvettes - Plugs - B154O0034791PLGEA00 Catalog Number : 0010391.000

Device Description : Disposable cuvettes for use with the Oxicom 2100 and 3000 oximeter.

Device Class : 2

Duns Number: 556957871

Premarket Exempt : No

Product Code : DQA

Prescription Use : No

Device Count : 1

Previous 1 2 3 4 5 6 Next