MEDIVATORS INC.

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

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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

Endoscope introducer kit (NWU) (9) PUMP, AIR, NON-MANUAL, FOR ENDOSCOPE (FEQ) (1) endoscopic irrigation/suction system (OCX) (1)

Premarket Exempt

No Yes

Clear

Custom Procedure Kit - 40677964028203 Catalog Number : 4005627

Device Description : Custom Procedure Kit includes Bedside Cleaning Tray, Intercept Detergent, Sponge Custom Procedure Kit includes Bedside Cleaning Tray, Intercept Detergent, Sponge, 5-piece Olympus DCA Kit, Absorb Pad, Surgical Lubricant, Gauze pads, Suction Tube and Biohazard Sticker

Device Class : 2

Duns Number: 068199363

Premarket Exempt : Yes

Product Code : NWU

Prescription Use : Yes

Device Count : 1

Custom Procedure Kit - 40677964028227 Catalog Number : 4005628

Device Description : Custom Procedure Kit includes Basin, Enzymatic Sponge, Transport Pad, Lubric Custom Procedure Kit includes Basin, Enzymatic Sponge, Transport Pad, Lubricating Jelly, Gauze, DOUBLE-HEADER CHANNEL-VALVE, and Biohazard Sticker

Device Class : 2

Duns Number: 068199363

Premarket Exempt : Yes

Product Code : NWU

Prescription Use : Yes

Device Count : 1

Custom Procedure Kit - 40677964030428 Catalog Number : 4005661

Device Description : Custom Procedure Kit includes Basin, Enzymatic Sponge, Transport Pad, 4-piece Ol Custom Procedure Kit includes Basin, Enzymatic Sponge, Transport Pad, 4-piece Olympus DCA Kit, Lubricant, Gauze Pads, Double-Header Channel-Valve, and Biohazard Sticker.

Device Class : 2

Duns Number: 068199363

Premarket Exempt : Yes

Product Code : NWU

Prescription Use : Yes

Device Count : 1

Custom Procedure Kit - 40677964030442 Catalog Number : 4005669

Device Description : Custom Procedure Kit includes Bedside Cleaning tray, Intercept Detergent, Sponge Custom Procedure Kit includes Bedside Cleaning tray, Intercept Detergent, Sponge, Olympus DCA Kit. Absorb Pad, Lubricating Jelly, Gauze Pads, Suction Tubing, and Biohazard Label.

Device Class : 2

Duns Number: 068199363

Premarket Exempt : Yes

Product Code : NWU

Prescription Use : Yes

Device Count : 1

Custom Procedure Kit - 40677964031555 Catalog Number : 4005680

Device Description : Customs Procedure Kit includes Via basin, Enzymatic Sponge, Olympic DCSA Kit, Tr Customs Procedure Kit includes Via basin, Enzymatic Sponge, Olympic DCSA Kit, Transport Pad, Lubricating Jelly, Gauze Pads, Suction Tubing, and Biohazard Sticker.

Device Class : 2

Duns Number: 068199363

Premarket Exempt : Yes

Product Code : NWU

Prescription Use : Yes

Device Count : 1

Endo Carry-on Procedure Kit - 40677964031579 Catalog Number : 4005618

Device Description : Endo Carry-on Procedure Kit includes Transport Pad, Intercept Bedside Kit, Gauze Endo Carry-on Procedure Kit includes Transport Pad, Intercept Bedside Kit, Gauze Pads, Lubricating Jelly, Suction Tubing, Syringe, Biohazard label, and Defendo Single Use Valves and Connector Kit for certain Olympus GI Endoscopes.

Device Class : 2

Duns Number: 068199363

Premarket Exempt : Yes

Product Code : NWU

Prescription Use : Yes

Device Count : 1

ENDOGATOR - 40677964031609 Catalog Number : 4005629

Device Description : ENDOGATOR Channel Adapter

Device Class : 2

Duns Number: 068199363

Premarket Exempt : No

Product Code : FEQ, OCX

Prescription Use : Yes

Device Count : 1

Custom Procedure Kit - 40677964031708 Catalog Number : 4005673

Device Description : Custom Procedure Kit includes Basin, Enzymatic Sponge, Transport Pad, Gauze, Custom Procedure Kit includes Basin, Enzymatic Sponge, Transport Pad, Gauze, DOUBLE-HEADER CHANNEL-VALVE, and Biohazard Sticker

Device Class : 2

Duns Number: 068199363

Premarket Exempt : Yes

Product Code : NWU

Prescription Use : Yes

Device Count : 1

Custom Procedure Kit - 40677964031722 Catalog Number : 4005749

Device Class : 2

Duns Number: 068199363

Premarket Exempt : Yes

Product Code : NWU

Prescription Use : Yes

Device Count : 1

Endo Carry-On Custom Procedure Kit - 40677964031746 Catalog Number : 4005872

Device Description : Endo Carry-On Custom Procedure Kit includes Basin, Enzymatic Sponge, Biopsy Valv Endo Carry-On Custom Procedure Kit includes Basin, Enzymatic Sponge, Biopsy Valve, Transport Pad, Lubricating Jelly, Gauze Pads, Suction Tube, Gown, and Biohazard Sticker.

Device Class : 2

Duns Number: 068199363

Premarket Exempt : Yes

Product Code : NWU

Prescription Use : Yes

Device Count : 1

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