Fresenius Medical Care Renal Therapies Group, LLC

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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

DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER) (KPO) (6) Accessories, Blood Circuit, Hemodialysis (KOC) (2) Set, Tubing, Blood, With And Without Anti-Regurgitation Valve (FJK) (2) ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS (KOC) (1)

Premarket Exempt

No Yes

Clear

NaturaLyte - 00840861101832 Catalog Number : 13-1251-1

Device Description : NaturaLyte 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

NaturaLyte - 00840861101849 Catalog Number : 13-2201-5

Device Description : NaturaLyte 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

NaturaLyte - 00840861101856 Catalog Number : 13-2231-2

Device Description : NaturaLyte 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

NaturaLyte - 00840861101863 Catalog Number : 13-2251-0

Device Description : NaturaLyte 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

NaturaLyte - 00840861101870 Catalog Number : 13-3231-1

Device Description : NaturaLyte 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

NaturaLyte - 00840861101887 Catalog Number : 13-3251-9

Device Description : NaturaLyte 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

CAREline - 00840861102075 Catalog Number : 0450007

Device Description : Dialyzer Holder Lock Sleeve

Device Class : 2

Duns Number: 079732391

Premarket Exempt : Yes

Product Code : KOC

Prescription Use : No

Device Count : 1

CombiSet SMARTECH - 00840861102259 Catalog Number :

Device Class : 2

Duns Number: 079732391

Premarket Exempt : No

Product Code : KOC, FJK

Prescription Use : Yes

Device Count : 1

CombiSet SMARTECH - 00840861102266 Catalog Number :

Device Class : 2

Duns Number: 079732391

Premarket Exempt : No

Product Code : KOC, FJK

Prescription Use : Yes

Device Count : 1

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