Nikkiso Belgium BVBA

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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) (6)

Premarket Exempt

Clear

ACCUSOL Dialysis Solution for CRRT - 09349285000154 Catalog Number : 5B9248

Device Description : Accusol 35 4K+ Solution is indicated for use as a dialysis solution in Continuou

Device Class :

Duns Number: 370482633

Premarket Exempt : No

Product Code : KPO

Prescription Use : Yes

Device Count : 1

ACCUSOL Dialysis Solution for CRRT - 09349285000161 Catalog Number : 5B9249

Device Description : Accusol 35 2K+ Solution is indicated for use as dialysis solution in Continuous

Device Class :

Duns Number: 370482633

Premarket Exempt : No

Product Code : KPO

Prescription Use : Yes

Device Count : 1

ACCUSOL Dialysis Solution for CRRT - 09349285000178 Catalog Number : 5B9250

Device Description : Accusol 35 0K+ 0DEX Solution is indicated for use as dialysis solution in Contin

Device Class :

Duns Number: 370482633

Premarket Exempt : No

Product Code : KPO

Prescription Use : Yes

Device Count : 1

ACCUSOL Dialysis Solution for CRRT - 09349285000185 Catalog Number : 5B9251

Device Description : Accusol 30 2K+ Solution is indicated for use as dialysis solutions in Continuous

Device Class : 2

Duns Number: 370482633

Premarket Exempt : No

Product Code : KPO

Prescription Use : Yes

Device Count : 1

ACCUSOL Dialysis Solution for CRRT - 09349285000192 Catalog Number : 5B9252

Device Description : Accusol 30 2K+ 0Ca++ Solution is indicated for use as dialysis solution in Conti

Device Class :

Duns Number: 370482633

Premarket Exempt : No

Product Code : KPO

Prescription Use : Yes

Device Count : 1

Premixed Dialysate for Hemodiafiltration - 09349285000208 Catalog Number : 5B7860

Device Description : Premixed Dialysate for Hemodiafiltration is indicated for acute dialysis modalit

Device Class : 2

Duns Number: 370482633

Premarket Exempt : No

Product Code : KPO

Prescription Use : Yes

Device Count : 1

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