Fresenius Medical Care Renal Therapies Group, LLC

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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

DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER) (KPO) (10)

Premarket Exempt

No Yes

Clear

Citrasate Dry - 00840861101429 Catalog Number : 0FD2251-DA

Device Description : Citrasate Dry, Dry Acid Concentrate for Bicarbonate Dialysis

Device Class : 2

Duns Number: 079732391

Premarket Exempt : No

Product Code : KPO

Prescription Use : Yes

Device Count : 1

Citrasate Dry - 00840861101436 Catalog Number : 0FD2301-DA

Device Description : Citrasate Dry, Dry Acid Concentrate for Bicarbonate Dialysis

Device Class : 2

Duns Number: 079732391

Premarket Exempt : No

Product Code : KPO

Prescription Use : Yes

Device Count : 1

Citrasate Dry - 00840861101443 Catalog Number : 0FD3231-DA

Device Description : Citrasate Dry, Dry Acid Concentrate for Bicarbonate Dialysis

Device Class : 2

Duns Number: 079732391

Premarket Exempt : No

Product Code : KPO

Prescription Use : Yes

Device Count : 1

Citrasate Dry - 00840861101450 Catalog Number : 0FD3251-DA

Device Description : Citrasate Dry, Dry Acid Concentrate for Bicarbonate Dialysis

Device Class : 2

Duns Number: 079732391

Premarket Exempt : No

Product Code : KPO

Prescription Use : Yes

Device Count : 1

Citrasate Dry - 00840861101467 Catalog Number : 0FD3301-DA

Device Description : Citrasate Dry, Dry Acid Concentrate for Bicarbonate Dialysis

Device Class : 2

Duns Number: 079732391

Premarket Exempt : No

Product Code : KPO

Prescription Use : Yes

Device Count : 1

GranuFlo - 00840861101474 Catalog Number : 0FD1251-3B

Device Description : GranuFlo Dry Acid Concentrate for Bicarbonate Dialysis

Device Class : 2

Duns Number: 079732391

Premarket Exempt : No

Product Code : KPO

Prescription Use : Yes

Device Count : 1

GranuFlo - 00840861101481 Catalog Number : 0FD2201-3B

Device Description : GranuFlo Dry Acid Concentrate for Bicarbonate Dialysis

Device Class : 2

Duns Number: 079732391

Premarket Exempt : No

Product Code : KPO

Prescription Use : Yes

Device Count : 1

GranuFlo - 00840861101528 Catalog Number : 0FD2231-3B

Device Description : GranuFlo Dry Acid Concentrate for Bicarbonate Dialysis

Device Class : 2

Duns Number: 079732391

Premarket Exempt : No

Product Code : KPO

Prescription Use : Yes

Device Count : 1

GranuFlo - 00840861101535 Catalog Number : 0FD2251-3B

Device Description : GranuFlo Dry Acid Concentrate for Bicarbonate Dialysis

Device Class : 2

Duns Number: 079732391

Premarket Exempt : No

Product Code : KPO

Prescription Use : Yes

Device Count : 1

GranuFlo - 00840861101542 Catalog Number : 0FD2301-3B

Device Description : GranuFlo Dry Acid Concentrate for Bicarbonate Dialysis

Device Class : 2

Duns Number: 079732391

Premarket Exempt : No

Product Code : KPO

Prescription Use : Yes

Device Count : 1

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