Fresenius Usa, Inc.

Address:4040 Nelson Ave,Concord,CA,94520,US

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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, high permeability with or without sealed dialysate system (KDI) (8) ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS (KOC) (1) Hemodialysis system for home use (ONW) (1)

Premarket Exempt

Clear

Crit-Line® - 00840861100552 Catalog Number : CL10041021

Device Description : Viewing window for CLiC technology

Device Class :

Duns Number: 076594100

Premarket Exempt : No

Product Code : KOC

Prescription Use : Yes

Device Count : 1

2008® Series Hemodialysis Machines - 00840861100859 Catalog Number :

Device Description : 2008K2 HEMODIALYSIS SYS. OLC/ DIASAFE PLS

Device Class : 2

Duns Number: 076594100

Premarket Exempt : No

Product Code : KDI

Prescription Use : Yes

Device Count : 1

2008® Series Hemodialysis Machines - 00840861100866 Catalog Number :

Device Description : 2008K2 MACHINE, SHORT CAB, OLC/DP, HP

Device Class : 2

Duns Number: 076594100

Premarket Exempt : No

Product Code : KDI

Prescription Use : Yes

Device Count : 1

2008® Series Hemodialysis Machines - 00840861100873 Catalog Number :

Device Description : 2008K2 HEMO SYSTEM, OPTIONAL 5th MODULE

Device Class : 2

Duns Number: 076594100

Premarket Exempt : No

Product Code : KDI

Prescription Use : Yes

Device Count : 1

2008® Series Hemodialysis Machines - 00840861100897 Catalog Number :

Device Description : 2008T HEMODIALYSIS SYS., with CDX

Device Class : 2

Duns Number: 076594100

Premarket Exempt : No

Product Code : KDI

Prescription Use : Yes

Device Count : 1

2008® Series Hemodialysis Machines - 00840861100903 Catalog Number :

Device Description : 2008T HEMODIALYSIS SYSTEM WITHOUT CDX

Device Class : 2

Duns Number: 076594100

Premarket Exempt : No

Product Code : KDI

Prescription Use : Yes

Device Count : 1

2008® Series Hemodialysis Machines - 00840861100910 Catalog Number :

Device Description : 2008T HEMODIALYSIS SYSTEM W/CDX W/BIBAG

Device Class : 2

Duns Number: 076594100

Premarket Exempt : No

Product Code : KDI

Prescription Use : Yes

Device Count : 1

2008® Series Hemodialysis Machines - 00840861100927 Catalog Number :

Device Description : 2008T GEN 2 BIBAG WITHOUT CDX

Device Class : 2

Duns Number: 076594100

Premarket Exempt : No

Product Code : KDI

Prescription Use : Yes

Device Count : 1

2008® Series Hemodialysis Machines - 00840861100934 Catalog Number :

Device Description : 2008T HD SYSTEM WITH CDX, CANADA

Device Class : 2

Duns Number: 076594100

Premarket Exempt : No

Product Code : KDI

Prescription Use : Yes

Device Count : 1

2008® Series Hemodialysis Machines - 00840861100941 Catalog Number :

Device Description : 2008K@HOME HEMODIALYSIS SYSTEM

Device Class : 2

Duns Number: 076594100

Premarket Exempt : No

Product Code : ONW

Prescription Use : Yes

Device Count : 1

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