MICHIGAN CRITICAL CARE CONSULTANTS, INC.

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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

Dual Lumen Ecmo Cannula (PZS) (5) Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (DWF) (4) Dilator, Vessel, For Percutaneous Catheterization (DRE) (1)

Premarket Exempt

No Yes

Clear

MC3 - 10854916006703 Catalog Number : 6394

Device Description : Soft Flow Aortic 21FR 7MM ANGLED FLANGE VENTED

Device Class : 2

Duns Number: 806687406

Premarket Exempt : No

Product Code : DWF

Prescription Use : Yes

Device Count : 1

MC3 - 10854916006727 Catalog Number : 7071

Device Description : Soft Flow Aortic 18FR 6MM ANGLED BULB NON VENTED

Device Class : 2

Duns Number: 806687406

Premarket Exempt : No

Product Code : DWF

Prescription Use : Yes

Device Count : 1

MC3 - 10854916006741 Catalog Number : 7072

Device Description : Soft Flow Aortic 18FR 6MM ANGLED BULB VENTED

Device Class : 2

Duns Number: 806687406

Premarket Exempt : No

Product Code : DWF

Prescription Use : Yes

Device Count : 1

MC3 - 10854916006765 Catalog Number : 7080

Device Description : Soft Flow Aortic 18FR 6MM ANGLED FLANGE VENTED

Device Class : 2

Duns Number: 806687406

Premarket Exempt : No

Product Code : DWF

Prescription Use : Yes

Device Count : 1

MC3 Crescent Jugular Dual Lumen Catheter - 10854916006789 Catalog Number : 70124

Device Description : Dual Lumen ECMO Cannula

Device Class : 2

Duns Number: 806687406

Premarket Exempt : No

Product Code : PZS

Prescription Use : Yes

Device Count : 1

MC3 Crescent Jugular Dual Lumen Catheter - 10854916006796 Catalog Number : 70126

Device Description : Dual Lumen ECMO Cannula

Device Class : 2

Duns Number: 806687406

Premarket Exempt : No

Product Code : PZS

Prescription Use : Yes

Device Count : 1

MC3 Crescent Jugular Dual Lumen Catheter - 10854916006802 Catalog Number : 70128

Device Description : Dual Lumen ECMO Cannula

Device Class : 2

Duns Number: 806687406

Premarket Exempt : No

Product Code : PZS

Prescription Use : Yes

Device Count : 1

MC3 Crescent Jugular Dual Lumen Catheter - 10854916006819 Catalog Number : 70130

Device Description : Dual Lumen ECMO Cannula

Device Class : 2

Duns Number: 806687406

Premarket Exempt : No

Product Code : PZS

Prescription Use : Yes

Device Count : 1

MC3 Crescent Jugular Dual Lumen Catheter - 10854916006826 Catalog Number : 70132

Device Description : Dual Lumen ECMO Cannula

Device Class : 2

Duns Number: 806687406

Premarket Exempt : No

Product Code : PZS

Prescription Use : Yes

Device Count : 1

MC3 Opus(tm) Vascular Access Kit - 10854916006833 Catalog Number : 21030

Device Description : Vascular Access Kit

Device Class :

Duns Number: 806687406

Premarket Exempt : No

Product Code : DRE

Prescription Use : Yes

Device Count : 1

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