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) (10)

Premarket Exempt

Clear

CANNULA 11MM TEFLON STERILE - 1/packaging - B154R39101410110 Catalog Number : 3910141.011

Device Description : CANNULA 11MM TEFLON STERILE - 1/packaging

Device Class : 2

Duns Number: 556957871

Premarket Exempt : No

Product Code : KDN

Prescription Use : No

Device Count : 1

CANNULA 12MM TEFLON STERILE - 1/packaging - B154R39101410120 Catalog Number : 3910141.012

Device Description : CANNULA 12MM TEFLON STERILE - 1/packaging

Device Class : 2

Duns Number: 556957871

Premarket Exempt : No

Product Code : KDN

Prescription Use : No

Device Count : 1

CANNULA 13MM TEFLON STERILE - 1/packaging - B154R39101410130 Catalog Number : 3910141.013

Device Description : CANNULA 13MM TEFLON STERILE - 1/packaging

Device Class : 2

Duns Number: 556957871

Premarket Exempt : No

Product Code : KDN

Prescription Use : No

Device Count : 1

CANNULA 14MM TEFLON STERILE - 1/packaging - B154R39101410140 Catalog Number : 3910141.014

Device Description : CANNULA 14MM TEFLON STERILE - 1/packaging

Device Class : 2

Duns Number: 556957871

Premarket Exempt : No

Product Code : KDN

Prescription Use : No

Device Count : 1

CANNULA 15MM TEFLON STERILE - 1/packaging - B154R39101410150 Catalog Number : 3910141.015

Device Description : CANNULA 15MM TEFLON STERILE - 1/packaging

Device Class : 2

Duns Number: 556957871

Premarket Exempt : No

Product Code : KDN

Prescription Use : No

Device Count : 1

CANNULA 16MM TEFLON STERILE - 1/packaging - B154R39101410160 Catalog Number : 3910141.016

Device Description : CANNULA 16MM TEFLON STERILE - 1/packaging

Device Class : 2

Duns Number: 556957871

Premarket Exempt : No

Product Code : KDN

Prescription Use : No

Device Count : 1

Cannula 2mm SS, Non-Sterile - B154R39101420020 Catalog Number : 3910142.002

Device Description : Cannula 2mm Stainless Steel, Non-Sterile

Device Class : 2

Duns Number: 556957871

Premarket Exempt : No

Product Code : KDN

Prescription Use : No

Device Count : 1

Cannula 3mm SS, Non-Sterile - B154R39101420030 Catalog Number : 3910142.003

Device Description : Stainless steel cannula 3mm, Non-sterile

Device Class : 2

Duns Number: 556957871

Premarket Exempt : No

Product Code : KDN

Prescription Use : No

Device Count : 1

Cannula 4mm SS, Non-Sterile - B154R39101420040 Catalog Number : 3910142.004

Device Description : Cannula 4mm Stainless Steel, Non-Sterile

Device Class : 2

Duns Number: 556957871

Premarket Exempt : No

Product Code : KDN

Prescription Use : No

Device Count : 1

Cannula 5mm SS, Non-Sterile - B154R39101420050 Catalog Number : 3910142.005

Device Description : Cannula 5mm Stainless Steel, Non-Sterile

Device Class : 2

Duns Number: 556957871

Premarket Exempt : No

Product Code : KDN

Prescription Use : No

Device Count : 1

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