Fresenius Medical Care Holdings, Inc.

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Device Description : F160NR Optiflux Dialyzer / High Flux / Polysulfone / 1.5 m2 / ETO / Single Use / 84 mL

Device Class : 2

Duns Number: 958291411

Premarket Exempt : No

Product Code : KDI

Prescription Use : Yes

Device Count : 1

Device Description : F180NR Optiflux Dialyzer / High Flux / Polysulfone / 1.7 m2 / ETO / Single Use / 97 mL

Device Class : 2

Duns Number: 958291411

Premarket Exempt : No

Product Code : KDI

Prescription Use : Yes

Device Count : 1

Device Description : F200NR Optiflux Dialyzer / High Flux / Polysulfone / 2.0 m2 / ETO / Single Use / 113 mL

Device Class : 2

Duns Number: 958291411

Premarket Exempt : No

Product Code : KDI

Prescription Use : Yes

Device Count : 1

Device Description : F160NR Optiflux Dialyzer / High Flux / Polysulfone / 1.5 m2 / Ebeam / Single Use / 87 mL

Device Class : 2

Duns Number: 958291411

Premarket Exempt : No

Product Code : FJI

Prescription Use : Yes

Device Count : 1

Device Description : F180NR Optiflux Dialyzer / High Flux / Polysulfone / 1.7 m2 / Ebeam / Single Use / 102 mL

Device Class : 2

Duns Number: 958291411

Premarket Exempt : No

Product Code : KDI

Prescription Use : Yes

Device Count : 1

Device Description : F200NR Optiflux Dialyzer / High Flux / Polysulfone / 1.9 m2 / Ebeam / Single Use / 113 mL

Device Class : 2

Duns Number: 958291411

Premarket Exempt : No

Product Code : KDI

Prescription Use : Yes

Device Count : 1

Device Description : F250NR Optiflux Dialyzer / High Flux / Polysulfone / 2.5 m2 / Ebeam / Single Use / 142 mL

Device Class : 2

Duns Number: 958291411

Premarket Exempt : No

Product Code : KDI

Prescription Use : Yes

Device Count : 1

Device Description : F160 Optiflux Ultra Dialyzer / High Flux / Polysulfone / 1.4 m2 / Ebeam / Single F160 Optiflux Ultra Dialyzer / High Flux / Polysulfone / 1.4 m2 / Ebeam / Single Use / 77 mL

Device Class : 2

Duns Number: 958291411

Premarket Exempt : No

Product Code : KDI

Prescription Use : Yes

Device Count : 1

Device Description : F180 Optiflux Ultra Dialyzer / High Flux / Polysulfone / 1.6 m2 / Ebeam / Single F180 Optiflux Ultra Dialyzer / High Flux / Polysulfone / 1.6 m2 / Ebeam / Single Use / 89 mL

Device Class : 2

Duns Number: 958291411

Premarket Exempt : No

Product Code : KDI

Prescription Use : Yes

Device Count : 1

Device Description : F190 Optiflux Ultra Dialyzer / High Flux / Polysulfone / 1.9 m2 / Ebeam / Single F190 Optiflux Ultra Dialyzer / High Flux / Polysulfone / 1.9 m2 / Ebeam / Single Use / 105 mL

Device Class : 2

Duns Number: 958291411

Premarket Exempt : No

Product Code : KDI

Prescription Use : Yes

Device Count : 1