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) (9) SET, TUBING, BLOOD, WITH AND WITHOUT ANTI-REGURGITATION VALVE (FJK) (1)

Premarket Exempt

No Yes

Clear

CAREline - 00840861100408 Catalog Number : 0342006

Device Class : 2

Duns Number: 079732391

Premarket Exempt : No

Product Code : FJK

Prescription Use : Yes

Device Count : 1

Citrasate - 00840861101337 Catalog Number : 08-1251-CA

Device Description : Citrasate 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

Citrasate - 00840861101344 Catalog Number : 08-2251-CA

Device Description : Citrasate 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

Citrasate - 00840861101351 Catalog Number : 08-3251-CA

Device Description : Citrasate 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

Citrasate - 00840861101368 Catalog Number : 13-1251-CA

Device Description : Citrasate Liquid Acid Concentrate for Bicarbonate Dialysis, Drum

Device Class : 2

Duns Number: 079732391

Premarket Exempt : No

Product Code : KPO

Prescription Use : Yes

Device Count : 1

Citrasate - 00840861101375 Catalog Number : 13-2251-CA

Device Description : Citrasate Liquid Acid Concentrate for Bicarbonate Dialysis, Drum

Device Class : 2

Duns Number: 079732391

Premarket Exempt : No

Product Code : KPO

Prescription Use : Yes

Device Count : 1

Citrasate - 00840861101382 Catalog Number : 13-3251-CA

Device Description : Citrasate Liquid Acid Concentrate for Bicarbonate Dialysis, Drum

Device Class : 2

Duns Number: 079732391

Premarket Exempt : No

Product Code : KPO

Prescription Use : Yes

Device Count : 1

Citrasate Dry - 00840861101399 Catalog Number : 0FD1231-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 - 00840861101405 Catalog Number : 0FD1251-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 - 00840861101412 Catalog Number : 0FD2231-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

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