OCEANIC MEDICAL PRODUCTS, 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

Gas-Machine, Anesthesia (BSZ) (4) Ventilator, Continuous, Facility Use (CBK) (2)

Premarket Exempt

Clear

Magellan Ventilator - 00864604000305 Catalog Number :

Device Class : 2

Duns Number: 796816515

Premarket Exempt : No

Product Code : CBK

Prescription Use : No

Device Count : 1

MaxO2Vent - 00864604000312 Catalog Number :

Device Class : 2

Duns Number: 796816515

Premarket Exempt : No

Product Code : CBK

Prescription Use : No

Device Count : 1

Magellan 2200 Model - 1 - 00864604000329 Catalog Number :

Device Class : 2

Duns Number: 796816515

Premarket Exempt : No

Product Code : BSZ

Prescription Use : No

Device Count : 1

Magellan 2200 Model - 2 - 00864604000336 Catalog Number :

Device Class : 2

Duns Number: 796816515

Premarket Exempt : No

Product Code : BSZ

Prescription Use : No

Device Count : 1

Magellan 2200 Model - 3 - 00864604000343 Catalog Number :

Device Class : 2

Duns Number: 796816515

Premarket Exempt : No

Product Code : BSZ

Prescription Use : No

Device Count : 1

Magellan 2200 Model - 3 - 00864604000367 Catalog Number :

Device Class : 2

Duns Number: 796816515

Premarket Exempt : No

Product Code : BSZ

Prescription Use : No

Device Count : 1

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