Fresenius Usa, Inc.

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

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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

Dialyzer, high permeability with or without sealed dialysate system (KDI) (8) System, peritoneal, automatic delivery (FKX) (1)

Premarket Exempt

Clear

Liberty® Select Cycler - 00840861102068 Catalog Number :

Device Description : Liberty® Select Cycler

Device Class : 2

Duns Number: 076594100

Premarket Exempt : No

Product Code : FKX

Prescription Use : Yes

Device Count : 1

2008T BlueStar Hemodialysis Machine - 00840861102082 Catalog Number :

Device Class : 2

Duns Number: 076594100

Premarket Exempt : No

Product Code : KDI

Prescription Use : Yes

Device Count : 1

2008T BlueStar Hemodialysis Machine - 00840861102099 Catalog Number :

Device Class : 2

Duns Number: 076594100

Premarket Exempt : No

Product Code : KDI

Prescription Use : Yes

Device Count : 1

2008T BlueStar Hemodialysis Machine - 00840861102105 Catalog Number :

Device Class : 2

Duns Number: 076594100

Premarket Exempt : No

Product Code : KDI

Prescription Use : Yes

Device Count : 1

2008T BlueStar Hemodialysis Machine - 00840861102112 Catalog Number :

Device Class : 2

Duns Number: 076594100

Premarket Exempt : No

Product Code : KDI

Prescription Use : Yes

Device Count : 1

Fresenius - 04046241091694 Catalog Number :

Device Description : BLUE BICARB CONCENTRATE WAND (US)

Device Class : 2

Duns Number: 076594100

Premarket Exempt : No

Product Code : KDI

Prescription Use : No

Device Count : 1

Fresenius - 04046241091700 Catalog Number :

Device Description : JUG WAND, BLUE

Device Class : 2

Duns Number: 076594100

Premarket Exempt : No

Product Code : KDI

Prescription Use : No

Device Count : 1

Fresenius - 04046241091717 Catalog Number :

Device Description : JUG WAND, RED

Device Class : 2

Duns Number: 076594100

Premarket Exempt : No

Product Code : KDI

Prescription Use : No

Device Count : 1

Fresenius - 04046241091731 Catalog Number :

Device Description : JUG WAND, WHITE

Device Class : 2

Duns Number: 076594100

Premarket Exempt : No

Product Code : KDI

Prescription Use : No

Device Count : 1

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