MEDICAL GRAPHICS CORPORATION

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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

Spirometer, Diagnostic (BZG) (9) Gas, Calibration (Specified Concentration) (BXK) (1)

Premarket Exempt

Yes No

Clear

MGC Diagnostics - 00810016251750 Catalog Number :

Device Description : PREVENT II FILTER KIT-ROUND-WHITE-FM

Device Class : 2

Duns Number: 094045622

Premarket Exempt : No

Product Code : BZG

Prescription Use : Yes

Device Count : 1

MGC Diagnostics - 00810016251767 Catalog Number :

Device Description : PREVENT II FILTER KIT-ROUND-WHITE-FM

Device Class : 2

Duns Number: 094045622

Premarket Exempt : No

Product Code : BZG

Prescription Use : Yes

Device Count : 1

MGC Diagnostics - 00810016251774 Catalog Number :

Device Description : PREVENT II FILTER KIT-ROUND-WHITE-FM

Device Class : 2

Duns Number: 094045622

Premarket Exempt : No

Product Code : BZG

Prescription Use : Yes

Device Count : 1

MGC Diagnostics - 00810016251804 Catalog Number :

Device Description : GAS HAST 15%O2, BAL N2

Device Class : 1

Duns Number: 094045622

Premarket Exempt : Yes

Product Code : BXK

Prescription Use : Yes

Device Count : 1

MGC Diagnostics - B3685367130010 Catalog Number : 536713-001

Device Description : preVent Filter

Device Class :

Duns Number: 094045622

Premarket Exempt : No

Product Code : BZG

Prescription Use : Yes

Device Count : 1

MGC Diagnostics - B3685367130020 Catalog Number : 536713-002

Device Description : FILTER FOR PREVENT FLOW SENSOR-OVAL

Device Class : 2

Duns Number: 094045622

Premarket Exempt : No

Product Code : BZG

Prescription Use : Yes

Device Count : 1

MGC Diagnostics - B3685367130030 Catalog Number : 536713-003

Device Description : FILTER FOR RESMON FOT-OVAL MOUTHPIECE

Device Class : 2

Duns Number: 094045622

Premarket Exempt : No

Product Code : BZG

Prescription Use : Yes

Device Count : 1

MGC Diagnostics - B3685367130040 Catalog Number : 536713-004

Device Description : PREVENT II FILTER OVAL LIP GUARD

Device Class : 2

Duns Number: 094045622

Premarket Exempt : No

Product Code : BZG

Prescription Use : Yes

Device Count : 1

MGC Diagnostics - B3685367190010 Catalog Number : 536719-001

Device Description : FILTER KIT 1

Device Class : 2

Duns Number: 094045622

Premarket Exempt : No

Product Code : BZG

Prescription Use : Yes

Device Count : 1

MGC Diagnostics - B368536719004 Catalog Number : 536719-004

Device Description : FILTER KIT 3

Device Class : 2

Duns Number: 094045622

Premarket Exempt : No

Product Code : BZG

Prescription Use : Yes

Device Count : 1

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