Medos Medizintechnik Aktiengesellschaft

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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

Oxygenator, Cardiopulmonary Bypass (DTZ) (6) Reservoir, Blood, Cardiopulmonary Bypass (DTN) (1)

Premarket Exempt

Clear

hilite - 04250358150070 Catalog Number : MW 6221 0100

Device Class : 2

Duns Number: 313013477

Premarket Exempt : No

Product Code : DTN

Prescription Use : Yes

Device Count : 1

hilite - 04250358151602 Catalog Number : MW 6202 0061

Device Description : The Medos hilite 7000 oxygenator is indicated for use in procedures requiring th The Medos hilite 7000 oxygenator is indicated for use in procedures requiring the extracorporeal oxygenation of and carbon dioxide removal from human blood. It is designed to operate at a blood flow rate of one (1.0) to seven (7.0) liters per minute.

Device Class :

Duns Number: 313013477

Premarket Exempt : No

Product Code : DTZ

Prescription Use : Yes

Device Count : 1

hilite - 04250358151619 Catalog Number : MW 6202 0L61

Device Description : The Medos hilite 7000 LT oxygenator is indicated for use in procedures requiring The Medos hilite 7000 LT oxygenator is indicated for use in procedures requiring the extracorporeal oxygenation of and carbon dioxide removal from human blood. It is designed to operate at a blood flow rate of one (1.0) to seven (7.0) liters per minute.

Device Class :

Duns Number: 313013477

Premarket Exempt : No

Product Code : DTZ

Prescription Use : Yes

Device Count : 1

hilite - 04250358151626 Catalog Number : MW 6205 0001

Device Description : The Medos hilite 2800 oxygenator is indicated for use in procedures requiring th The Medos hilite 2800 oxygenator is indicated for use in procedures requiring the extracorporeal oxygenation of and carbon dioxide removal from human blood. It is designed to operate at a blood flow rate up to 2.8 liters per minute.

Device Class : 2

Duns Number: 313013477

Premarket Exempt : No

Product Code : DTZ

Prescription Use : Yes

Device Count : 1

hilite - 04250358151633 Catalog Number : MW 6205 0L01

Device Description : The Medos hilite 2400 LT oxygenator is indicated for use in procedures requiring The Medos hilite 2400 LT oxygenator is indicated for use in procedures requiring the extracorporeal oxygenation of and carbon dioxide removal from human blood. It is designed to operate at a blood flow rate up to 2.4 liters per minute.

Device Class : 2

Duns Number: 313013477

Premarket Exempt : No

Product Code : DTZ

Prescription Use : Yes

Device Count : 1

hilite - 04250358151640 Catalog Number : MW 6208 0001

Device Description : The Medos hilite 1000 oxygenator is indicated for use in procedures requiring th The Medos hilite 1000 oxygenator is indicated for use in procedures requiring the extracorporeal oxygenation of and carbon dioxide removal from human blood. It is designed to operate at a blood flow rate of 0.2 to 1.0 liters per minute.

Device Class : 2

Duns Number: 313013477

Premarket Exempt : No

Product Code : DTZ

Prescription Use : Yes

Device Count : 1

hilite - 04250358151657 Catalog Number : MW 6208 0L01

Device Description : The Medos hilite 800 LT oxygenator is indicated for use in procedures requiring The Medos hilite 800 LT oxygenator is indicated for use in procedures requiring the extracorporeal oxygenation of and carbon dioxide removal from human blood. It is designed to operate at a blood flow rate of 0.2 to 0.8 liters per minute.

Device Class : 2

Duns Number: 313013477

Premarket Exempt : No

Product Code : DTZ

Prescription Use : Yes

Device Count : 1

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