MICHIGAN CRITICAL CARE CONSULTANTS, INC.

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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

Dual Lumen Ecmo Cannula (PZS) (5) Oxygenator, Long Term Support Greater Than 6 Hours (BYS) (2) Accessory Equipment, Cardiopulmonary Bypass (KRI) (1)

Premarket Exempt

No Yes

Clear

MC3 Nautilus (tm) Smart ECMO Module - 10854916006871 Catalog Number : 48135

Device Description : Nautilus ECMO oxygenators are diffusion membrane oxygenators used in extracorpor Nautilus ECMO oxygenators are diffusion membrane oxygenators used in extracorporeal life support procedures to oxygenate blood, remove carbon dioxide and regulate blood temperature. Blood enters the device and passes through both the heat exchange membrane, where temperature is adjusted, and the gas transfer membrane, where oxygen is added and carbon dioxide is removed. Smart ECMO Module device contains integrated sensors with an electronic touch screen display. The following measured parameters are visible on the electronic display: inlet pressure, inlet oxygen saturation, outlet pressure, outlet oxygen saturation, and outlet blood temperature.

Device Class : 2

Duns Number: 806687406

Premarket Exempt : No

Product Code : BYS

Prescription Use : Yes

Device Count : 1

MC3 Nautilus(tm) ECMO Oxygenator - 10854916006888 Catalog Number : 48145

Device Description : Nautilus ECMO oxygenators are diffusion membrane oxygenators used in extracorpo Nautilus ECMO oxygenators are diffusion membrane oxygenators used in extracorporeal life support procedures to oxygenate blood, remove carbon dioxide and regulate blood temperature. Blood enters the device and passes through both the heat exchange membrane, where temperature is adjusted, and the gas transfer membrane, where oxygen is added and carbon dioxide is removed.

Device Class : 2

Duns Number: 806687406

Premarket Exempt : No

Product Code : BYS

Prescription Use : Yes

Device Count : 1

MC3 Crescent(tm) Jugular Dual Lumen Catheter 24 FR - 10854916006918 Catalog Number : 70124

Device Description : Jugular Dual Lumen Catheter 24 FR, CE Mark

Device Class : 2

Duns Number: 806687406

Premarket Exempt : No

Product Code : PZS

Prescription Use : Yes

Device Count : 1

MC3 Crescent(tm) Jugular Dual Lumen Catheter - 10854916006925 Catalog Number : 70126

Device Description : Jugular Dual Lumen Catheter 26 Fr

Device Class : 2

Duns Number: 806687406

Premarket Exempt : No

Product Code : PZS

Prescription Use : Yes

Device Count : 1

MC3 Crescent(tm) Jugular Dual Lumen Catheter - 10854916006932 Catalog Number : 70128

Device Description : Jugular Dual Lumen Catheter 28 Fr

Device Class : 2

Duns Number: 806687406

Premarket Exempt : No

Product Code : PZS

Prescription Use : Yes

Device Count : 1

MC3 Crescent(tm) Jugular Dual Lumen Catheter - 10854916006949 Catalog Number : 70130

Device Description : Jugular Dual Lumen Catheter 30 Fr

Device Class : 2

Duns Number: 806687406

Premarket Exempt : No

Product Code : PZS

Prescription Use : Yes

Device Count : 1

MC3 Crescent(tm) Jugular Dual Lumen Catheter - 10854916006956 Catalog Number : 70132

Device Description : Jugular Dual Lumen Catheter, 32 Fr

Device Class : 2

Duns Number: 806687406

Premarket Exempt : No

Product Code : PZS

Prescription Use : Yes

Device Count : 1

MC3 Nautilus Oxygenator Holder - 10854916006963 Catalog Number : 48160

Device Description : Cardiopulmonary Accessory Equipment.Bracket for Oxygenator

Device Class : 1

Duns Number: 806687406

Premarket Exempt : Yes

Product Code : KRI

Prescription Use : No

Device Count : 1

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