Fresenius Medical Care Holdings, Inc.

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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, CAPILLARY, HOLLOW FIBER (FJI) (4) Dialyzer, high permeability with or without sealed dialysate system (KDI) (4) HEMODIALYZER, RE-USE, HIGH FLUX (MSF) (2)

Premarket Exempt

Clear

Hemoflow™ - 00840861100019 Catalog Number :

Device Description : F3 Hemoflow Dialyzer / Low Flux / Polysulfone / 0.3 m2 / ETO / Low Volume / Sing F3 Hemoflow Dialyzer / Low Flux / Polysulfone / 0.3 m2 / ETO / Low Volume / Single Use / 26 mL

Device Class : 2

Duns Number: 958291411

Premarket Exempt : No

Product Code : FJI

Prescription Use : Yes

Device Count : 1

Hemoflow™ - 00840861100026 Catalog Number :

Device Description : F4 Hemoflow Dialyzer / Low Flux / Polysulfone / 0.7 m2 / ETO / Low Volume / Sing F4 Hemoflow Dialyzer / Low Flux / Polysulfone / 0.7 m2 / ETO / Low Volume / Single Use / 45 mL

Device Class : 2

Duns Number: 958291411

Premarket Exempt : No

Product Code : FJI

Prescription Use : Yes

Device Count : 1

Hemoflow™ - 00840861100033 Catalog Number :

Device Description : F6 Hemoflow Dialyzer / Low Flux / Polysulfone / 1.3 m2 / ETO / Multiple Use / 82 mL

Device Class : 2

Duns Number: 958291411

Premarket Exempt : No

Product Code : FJI

Prescription Use : Yes

Device Count : 1

Hemoflow™ - 00840861100040 Catalog Number :

Device Description : F8 Hemoflow Dialyzer / Low Flux / Polysulfone / 1.8 m2 / ETO / Multiple Use / 110 mL

Device Class : 2

Duns Number: 958291411

Premarket Exempt : No

Product Code : FJI

Prescription Use : Yes

Device Count : 1

Hemoflow™ - 00840861100057 Catalog Number :

Device Description : F60A Hemoflow Dialyzer / High Flux / Polysulfone / 1.3 m2 / ETO / Multiple Use / 82 mL

Device Class : 2

Duns Number: 958291411

Premarket Exempt : No

Product Code : MSF

Prescription Use : Yes

Device Count : 1

Hemoflow™ - 00840861100064 Catalog Number :

Device Description : F80A Hemoflow Dialyzer / High Flux / Polysulfone / 1.8 m2 / ETO / Multiple Use / 110 mL

Device Class : 2

Duns Number: 958291411

Premarket Exempt : No

Product Code : MSF

Prescription Use : Yes

Device Count : 1

Optiflux® - 00840861100071 Catalog Number :

Device Description : F16NR Optiflux Dialyzer / Low Flux / Polysulfone / 1.5 m2 / Ebeam / Single Use / 84 mL

Device Class : 2

Duns Number: 958291411

Premarket Exempt : No

Product Code : KDI

Prescription Use : Yes

Device Count : 1

Optiflux® - 00840861100088 Catalog Number :

Device Description : F18NR Optiflux Dialyzer / Low Flux / Polysulfone / 1.8 m2 / Ebeam / Single Use / 103 mL

Device Class :

Duns Number: 958291411

Premarket Exempt : No

Product Code : KDI

Prescription Use : Yes

Device Count : 1

Optiflux® - 00840861100095 Catalog Number :

Device Description : F180A Optiflux Dialyzer / High Flux / Polysulfone / 1.8 m2 / ETO / Multiple Use / 99 mL

Device Class : 2

Duns Number: 958291411

Premarket Exempt : No

Product Code : KDI

Prescription Use : Yes

Device Count : 1

Optiflux® - 00840861100101 Catalog Number :

Device Description : F200A Optiflux Dialyzer / High Flux / Polysulfone / 2.0 m2 / ETO / Multiple Use / 113 mL

Device Class : 2

Duns Number: 958291411

Premarket Exempt : No

Product Code : KDI

Prescription Use : Yes

Device Count : 1

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