Fresenius Medical Care Holdings, Inc.

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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

SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE (FJK) (8) ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS (KOC) (1) Dialyzer, high permeability with or without sealed dialysate system (KDI) (1)

Premarket Exempt

Clear

Optiflux® Ultra - 00840861100217 Catalog Number :

Device Description : F210 Optiflux Ultra Dialyzer / High Flux / Polysulfone / 2.2 m2 / Ebeam / Single F210 Optiflux Ultra Dialyzer / High Flux / Polysulfone / 2.2 m2 / Ebeam / Single Use / 124 mL

Device Class : 2

Duns Number: 958291411

Premarket Exempt : No

Product Code : KDI

Prescription Use : Yes

Device Count : 1

CombiSet - 00840861100224 Catalog Number : 03-2621-5

Device Description : Post-pump, 8.0 mm

Device Class : 2

Duns Number: 958291411

Premarket Exempt : No

Product Code : FJK

Prescription Use : Yes

Device Count : 1

CombiSet - 00840861100231 Catalog Number : 03-2622-3

Device Description : Pre-pump, 8.0 mm

Device Class : 2

Duns Number: 958291411

Premarket Exempt : No

Product Code : FJK

Prescription Use : Yes

Device Count : 1

CombiSet - 00840861100248 Catalog Number : 03-2630-6

Device Description : Pre-pump, 6.35 mm

Device Class : 2

Duns Number: 958291411

Premarket Exempt : No

Product Code : FJK

Prescription Use : Yes

Device Count : 1

CombiSet - 00840861100255 Catalog Number : 03-2631-4

Device Description : Post-pump, 6.35 mm

Device Class : 2

Duns Number: 958291411

Premarket Exempt : No

Product Code : FJK

Prescription Use : Yes

Device Count : 1

CombiSet - 00840861100262 Catalog Number : 03-2692-6

Device Description : Pre-pump, 6.35 mm, low volume

Device Class : 2

Duns Number: 958291411

Premarket Exempt : No

Product Code : FJK

Prescription Use : Yes

Device Count : 1

CombiSet - 00840861100286 Catalog Number : 03-2696-7

Device Description : 8.0 mm, single needle

Device Class : 2

Duns Number: 958291411

Premarket Exempt : No

Product Code : FJK

Prescription Use : Yes

Device Count : 1

CombiSet - 00840861100293 Catalog Number : 03-2722-9

Device Description : Pre-pump, 8.0 mm

Device Class : 2

Duns Number: 958291411

Premarket Exempt : No

Product Code : FJK

Prescription Use : Yes

Device Count : 1

CombiSet - 00840861100309 Catalog Number : 03-2742-9

Device Description : Pre-pump, 8.0 mm

Device Class : 2

Duns Number: 958291411

Premarket Exempt : No

Product Code : FJK

Prescription Use : Yes

Device Count : 1

CombiSet Twister - 00840861100316 Catalog Number : 03-2794-0

Device Description : Pre-pump, 8.0 mm, with Twister® Reverse Access Flow Device

Device Class : 2

Duns Number: 958291411

Premarket Exempt : No

Product Code : KOC

Prescription Use : Yes

Device Count : 1

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