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 6mm SS, Non-Sterile - B154R39101420060 Catalog Number : 3910142.006

Device Description : Cannula 6mm Stainless Steel, Non-Sterile

Device Class : 2

Duns Number: 556957871

Premarket Exempt : No

Product Code : KDN

Prescription Use : No

Device Count : 1

Cannula 7mm SS, Non-Sterile - B154R39101420070 Catalog Number : 3910142.007

Device Description : Cannula 7mm Stainless Steel, Non-Sterile

Device Class : 2

Duns Number: 556957871

Premarket Exempt : No

Product Code : KDN

Prescription Use : No

Device Count : 1

Cannula 8mm SS, Non-Sterile - B154R39101420080 Catalog Number : 3910142.008

Device Description : Cannula 8mm Stainless Steel, Non-Sterile

Device Class : 2

Duns Number: 556957871

Premarket Exempt : No

Product Code : KDN

Prescription Use : No

Device Count : 1

Cannula 9mm SS, Non-Sterile - B154R39101420090 Catalog Number : 3910142.009

Device Description : Cannula 9mm Stainless Steel, Non-Sterile

Device Class : 2

Duns Number: 556957871

Premarket Exempt : No

Product Code : KDN

Prescription Use : No

Device Count : 1

Cannula 10mm SS, Non-Sterile - B154R39101420100 Catalog Number : 3910142.010

Device Description : Cannula 10mm Stainless Steel, Non-Sterile

Device Class : 2

Duns Number: 556957871

Premarket Exempt : No

Product Code : KDN

Prescription Use : No

Device Count : 1

Cannula 11mm SS, Non-Sterile - B154R39101420110 Catalog Number : 3910142.011

Device Description : Cannula 11mm Stainless Steel, Non-Sterile

Device Class : 2

Duns Number: 556957871

Premarket Exempt : No

Product Code : KDN

Prescription Use : No

Device Count : 1

Cannula 12mm SS, Non-Sterile - B154R39101420120 Catalog Number : 3910142.012

Device Description : Cannula 12mm Stainless Steel, Non-Sterile

Device Class : 2

Duns Number: 556957871

Premarket Exempt : No

Product Code : KDN

Prescription Use : No

Device Count : 1

Cannula 13mm SS, Non-Sterile - B154R39101420130 Catalog Number : 3910142.013

Device Description : Cannula 13mm Stainless Steel, Non-Sterile

Device Class : 2

Duns Number: 556957871

Premarket Exempt : No

Product Code : KDN

Prescription Use : No

Device Count : 1

Cannula 14mm SS, Non-Sterile - B154R39101420140 Catalog Number : 3910142.014

Device Description : Cannula 14mm Stainless Steel, Non-Sterile

Device Class : 2

Duns Number: 556957871

Premarket Exempt : No

Product Code : KDN

Prescription Use : No

Device Count : 1

Trident Cannula - B154R39201400230 Catalog Number : 3920140.023

Device Description : RM3 Accessory Trident Cannula

Device Class : 2

Duns Number: 556957871

Premarket Exempt : No

Product Code : KDN

Prescription Use : No

Device Count : 1

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