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

NaturaLyte - 00840861101672 Catalog Number : 08-2201-5

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 - 00840861101689 Catalog Number : 08-2231-2

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 - 00840861101696 Catalog Number : 08-2251-0

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 - 00840861101702 Catalog Number : 08-2301-3

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 - 00840861101719 Catalog Number : 08-2351-8

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 - 00840861101726 Catalog Number : 08-3201-4

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 - 00840861101733 Catalog Number : 08-3231-1

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 - 00840861101740 Catalog Number : 08-3251-9

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 - 00840861101757 Catalog Number : 08-3301-2

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 - 00840861101801 Catalog Number : 08-4231-0

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

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