MEDIVATORS INC.

MEDIVATORS INC.

Address:3150 Pollok Drive,Conroe,TX,77303,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) (6) Dialyzer, High Permeability With Or Without Sealed Dialysate System (KDI) (3) Disinfectant, Medical Devices (LRJ) (1)

Premarket Exempt

No Yes

Clear

Renaflo II Hemofilter - 00677964000065 Catalog Number :

Device Class : 2

Duns Number: 068199363

Premarket Exempt : No

Product Code : KDI

Prescription Use : No

Device Count : 1

Renaflo II Hemofilter - 00677964000072 Catalog Number :

Device Class : 2

Duns Number: 068199363

Premarket Exempt : No

Product Code : KDI

Prescription Use : No

Device Count : 1

Renaflo II Hemofilter - 00677964000089 Catalog Number :

Device Class : 2

Duns Number: 068199363

Premarket Exempt : No

Product Code : KDI

Prescription Use : No

Device Count : 1

Actril Cold Sterilant - 00677964000249 Catalog Number :

Device Class : 2

Duns Number: 068199363

Premarket Exempt : No

Product Code : FKQ

Prescription Use : No

Device Count : 1

Renalin - 00677964000287 Catalog Number : 78336000

Device Description : Renalin

Device Class : 1

Duns Number: 068199363

Premarket Exempt : No

Product Code : LRJ

Prescription Use : No

Device Count : 1

Actril Cold Sterilant - 00677964000294 Catalog Number :

Device Class : 2

Duns Number: 068199363

Premarket Exempt : No

Product Code : FKQ

Prescription Use : No

Device Count : 1

Centrisol Bicarbonate Concentrate Powder - 00677964000300 Catalog Number :

Device Class : 2

Duns Number: 068199363

Premarket Exempt : No

Product Code : FKQ

Prescription Use : No

Device Count : 1

Centrisol Bicarbonate Concentrate Powder - 00677964000317 Catalog Number :

Device Class : 2

Duns Number: 068199363

Premarket Exempt : No

Product Code : FKQ

Prescription Use : No

Device Count : 1

Centrisol Bicarbonate Concentrate Powder - 00677964000324 Catalog Number :

Device Class : 2

Duns Number: 068199363

Premarket Exempt : No

Product Code : FKQ

Prescription Use : No

Device Count : 1

Renasol Bicarbonate Concentrate Powder - 00677964000331 Catalog Number :

Device Class : 2

Duns Number: 068199363

Premarket Exempt : No

Product Code : FKQ

Prescription Use : No

Device Count : 1

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