Fresenius Medical Care AG & Co. KGaA

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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

Dialyzer, high permeability with or without sealed dialysate system (KDI) (1) SUBSYSTEM, WATER PURIFICATION (FIP) (1)

Premarket Exempt

Clear

Hemoflow™ - 04039361001100 Catalog Number :

Device Description : F40S Hemoflow Dialyzer / High Flux / Polysulfone / 0.7 m2 / Steam / Single Use / 42 mL

Device Class : 2

Duns Number: 324661834

Premarket Exempt : No

Product Code : KDI

Prescription Use : Yes

Device Count : 1

Diasafe - 04039361001384 Catalog Number : 5008203

Device Description : FILTER, DIASAFE PLUS

Device Class : 2

Duns Number: 324661834

Premarket Exempt : No

Product Code : FIP

Prescription Use : No

Device Count : 1

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