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

Yes No

Clear

GranuFlo - 00840861101573 Catalog Number : 0FD3201-3B

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 - 00840861101580 Catalog Number : 0FD3231-3B

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 - 00840861101597 Catalog Number : 0FD3251-3B

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 - 00840861101603 Catalog Number : 0FD3301-3B

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

NaturaLyte - 00840861101610 Catalog Number : 08-0231-4

Device Description : NaturaLyte Liquid Acid Concentrate for Bicarbonate Dialysis, Case

Device Class : 2

Duns Number: 079732391

Premarket Exempt : No

Product Code : KPO

Prescription Use : Yes

Device Count : 1

NaturaLyte - 00840861101627 Catalog Number : 08-1001-0

Device Description : NaturaLyte Liquid Acid Concentrate for Bicarbonate Dialysis, Case

Device Class : 2

Duns Number: 079732391

Premarket Exempt : No

Product Code : KPO

Prescription Use : Yes

Device Count : 1

NaturaLyte - 00840861101634 Catalog Number : 08-1201-8

Device Description : NaturaLyte Liquid Acid Concentrate for Bicarbonate Dialysis, Case

Device Class : 2

Duns Number: 079732391

Premarket Exempt : No

Product Code : KPO

Prescription Use : Yes

Device Count : 1

NaturaLyte - 00840861101641 Catalog Number : 08-1231-3

Device Description : NaturaLyte Liquid Acid Concentrate for Bicarbonate Dialysis, Case

Device Class : 2

Duns Number: 079732391

Premarket Exempt : No

Product Code : KPO

Prescription Use : Yes

Device Count : 1

NaturaLyte - 00840861101658 Catalog Number : 08-1251-1

Device Description : NaturaLyte Liquid Acid Concentrate for Bicarbonate Dialysis, Case

Device Class : 2

Duns Number: 079732391

Premarket Exempt : No

Product Code : KPO

Prescription Use : Yes

Device Count : 1

NaturaLyte - 00840861101665 Catalog Number : 08-1301-4

Device Description : NaturaLyte Liquid Acid Concentrate for Bicarbonate Dialysis, Case

Device Class : 2

Duns Number: 079732391

Premarket Exempt : No

Product Code : KPO

Prescription Use : Yes

Device Count : 1

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