MEDIVATORS INC.

Address:14605 28th Ave North,MINNEAPOLIS,MN,55447,US

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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

System, Dialysate Delivery, Central Multiple Patient (FKQ) (8) Dialyzer Reprocessing System (LIF) (1) Dialyzer, High Permeability With Or Without Sealed Dialysate System (KDI) (1)

Premarket Exempt

No Yes

Clear

Hemocor HPH - 00677964000867 Catalog Number :

Device Description : High Performance Hemoconcentrator

Device Class : 2

Duns Number: 068199363

Premarket Exempt : No

Product Code : KDI

Prescription Use : No

Device Count : 1

Centrisol Acid Concentrate - 00677964005367 Catalog Number :

Device Class : 2

Duns Number: 068199363

Premarket Exempt : No

Product Code : FKQ

Prescription Use : No

Device Count : 1

Centrisol Acid Concentrate - 00677964005527 Catalog Number :

Device Class : 2

Duns Number: 068199363

Premarket Exempt : No

Product Code : FKQ

Prescription Use : No

Device Count : 1

Centrisol Acid Concentrate - 00677964005732 Catalog Number :

Device Class : 2

Duns Number: 068199363

Premarket Exempt : No

Product Code : FKQ

Prescription Use : No

Device Count : 1

Centrisol Acid Concentrate - 00677964005794 Catalog Number :

Device Class : 2

Duns Number: 068199363

Premarket Exempt : No

Product Code : FKQ

Prescription Use : No

Device Count : 1

Centrisol Acid Concentrate - 00677964005855 Catalog Number :

Device Class : 2

Duns Number: 068199363

Premarket Exempt : No

Product Code : FKQ

Prescription Use : No

Device Count : 1

Centrisol Acid Concentrate - 00677964006012 Catalog Number :

Device Class : 2

Duns Number: 068199363

Premarket Exempt : No

Product Code : FKQ

Prescription Use : No

Device Count : 1

Renasol Acid Concentrate - 00677964006180 Catalog Number :

Device Class : 2

Duns Number: 068199363

Premarket Exempt : No

Product Code : FKQ

Prescription Use : No

Device Count : 1

Renasol Acid Concentrate - 00677964006272 Catalog Number :

Device Class : 2

Duns Number: 068199363

Premarket Exempt : No

Product Code : FKQ

Prescription Use : No

Device Count : 1

Renalin Residual Test Strips - 00677964007972 Catalog Number :

Device Class :

Duns Number: 068199363

Premarket Exempt : No

Product Code : LIF

Prescription Use : No

Device Count : 1

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