Fresenius Usa, Inc.

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

Want to know more about this Organization? Request more information now!

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

ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS (KOC) (3) Hemodialysis system for home use (ONW) (3) DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER) (KPO) (2) SYSTEM, PERITONEAL, AUTOMATIC DELIVERY (FKX) (2)

Premarket Exempt

Clear

2008® Series Hemodialysis Machines - 00840861100958 Catalog Number :

Device Description : 2008K@HOME MACHINE, SHORT CAB, OLC/DP,HP

Device Class : 2

Duns Number: 076594100

Premarket Exempt : No

Product Code : ONW

Prescription Use : Yes

Device Count : 1

2008® Series Hemodialysis Machines - 00840861100965 Catalog Number :

Device Description : 2008K@HOME HEMODIALYSIS SYSTEM W/ BIBAG

Device Class : 2

Duns Number: 076594100

Premarket Exempt : No

Product Code : ONW

Prescription Use : Yes

Device Count : 1

Liberty® - 00840861100972 Catalog Number :

Device Description : Liberty® Cycler

Device Class : 2

Duns Number: 076594100

Premarket Exempt : No

Product Code : FKX

Prescription Use : Yes

Device Count : 1

Liberty® PDx - 00840861100989 Catalog Number :

Device Description : Liberty® PDx CYCLER

Device Class : 2

Duns Number: 076594100

Premarket Exempt : No

Product Code : FKX

Prescription Use : Yes

Device Count : 1

Dry Acid Dissolution Unit - 00840861100996 Catalog Number :

Device Description : 132 Gallon

Device Class : 2

Duns Number: 076594100

Premarket Exempt : No

Product Code : KPO

Prescription Use : Yes

Device Count : 1

Dry Acid Dissolution Unit - 00840861101009 Catalog Number :

Device Description : 99 Gallon

Device Class : 2

Duns Number: 076594100

Premarket Exempt : No

Product Code : KPO

Prescription Use : Yes

Device Count : 1

WetAlert™ wireless wetness detector - 00840861101023 Catalog Number :

Device Description : WetAlert™ wireless wetness detector

Device Class : 2

Duns Number: 076594100

Premarket Exempt : No

Product Code : ONW

Prescription Use : Yes

Device Count : 1

Crit-Line® - 00840861101122 Catalog Number :

Device Description : Blood Volume Monitor

Device Class : 2

Duns Number: 076594100

Premarket Exempt : No

Product Code : KOC

Prescription Use : Yes

Device Count : 1

Crit-Line® - 00840861101139 Catalog Number :

Device Description : Crit-Line in a Clip

Device Class : 2

Duns Number: 076594100

Premarket Exempt : No

Product Code : KOC

Prescription Use : Yes

Device Count : 1

Crit-Line® - 00840861102020 Catalog Number : 191058

Device Description : Blood Chamber II

Device Class :

Duns Number: 076594100

Premarket Exempt : No

Product Code : KOC

Prescription Use : Yes

Device Count : 1

Previous 1 2 3 Next