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

RM3 Accessory - Filter/Adapter - B154R39000560013 Catalog Number : 3900056.001

Device Description : Filter/Adapter for RM3 Control Unit. Contains DIs: 25ct of both 3180003005 and Filter/Adapter for RM3 Control Unit. Contains DIs: 25ct of both 3180003005 and 32000910005

Device Class : 2

Duns Number: 556957871

Premarket Exempt : No

Product Code : KDN

Prescription Use : No

Device Count : 1

RM3 Tool Kit - B154R39100010043 Catalog Number : 3910001.004

Device Description : RM3 Tool Kit

Device Class : 2

Duns Number: 556957871

Premarket Exempt : No

Product Code : KDN

Prescription Use : No

Device Count : 1

CANNULA 3MM TEFLON STERILE - 1/packaging - B154R39101410030 Catalog Number : 3910141.003

Device Description : CANNULA 3MM TEFLON STERILE - 1/packaging

Device Class : 2

Duns Number: 556957871

Premarket Exempt : No

Product Code : KDN

Prescription Use : No

Device Count : 1

CANNULA 4MM TEFLON STERILE - 1/packaging - B154R39101410040 Catalog Number : 3910141.004

Device Description : CANNULA 4MM TEFLON STERILE - 1/packaging

Device Class : 2

Duns Number: 556957871

Premarket Exempt : No

Product Code : KDN

Prescription Use : No

Device Count : 1

CANNULA 5MM TEFLON STERILE - 1/packaging - B154R39101410050 Catalog Number : 3910141.005

Device Description : CANNULA 5MM TEFLON STERILE - 1/packaging

Device Class : 2

Duns Number: 556957871

Premarket Exempt : No

Product Code : KDN

Prescription Use : No

Device Count : 1

CANNULA 6MM TEFLON STERILE - 1/packaging - B154R39101410060 Catalog Number : 3910141.006

Device Description : CANNULA 6MM TEFLON STERILE - 1/packaging

Device Class : 2

Duns Number: 556957871

Premarket Exempt : No

Product Code : KDN

Prescription Use : No

Device Count : 1

CANNULA 7MM TEFLON STERILE - 1/packaging - B154R39101410070 Catalog Number : 3910141.007

Device Description : CANNULA 7MM TEFLON STERILE - 1/packaging

Device Class : 2

Duns Number: 556957871

Premarket Exempt : No

Product Code : KDN

Prescription Use : No

Device Count : 1

CANNULA 8MM TEFLON STERILE - 1/packaging - B154R39101410080 Catalog Number : 3910141.008

Device Description : CANNULA 8MM TEFLON STERILE - 1/packaging

Device Class : 2

Duns Number: 556957871

Premarket Exempt : No

Product Code : KDN

Prescription Use : No

Device Count : 1

CANNULA 9MM TEFLON STERILE - 1/packaging - B154R39101410090 Catalog Number : 3910141.009

Device Description : CANNULA 9MM TEFLON STERILE - 1/packaging

Device Class : 2

Duns Number: 556957871

Premarket Exempt : No

Product Code : KDN

Prescription Use : No

Device Count : 1

CANNULA 10MM TEFLON STERILE - 1/packaging - B154R39101410100 Catalog Number : 3910141.010

Device Description : CANNULA 10MM TEFLON STERILE - 1/packaging

Device Class : 2

Duns Number: 556957871

Premarket Exempt : No

Product Code : KDN

Prescription Use : No

Device Count : 1

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