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) (5) Computer, Oxygen-Uptake (BZL) (3) Plethysmograph, Pressure (CCM) (2)

Premarket Exempt

No Yes

Clear

MGC Diagnostics - 00810016250203 Catalog Number : 800860-011

Device Description : Ultima System PFX CardiO2 - 120V

Device Class : 2

Duns Number: 094045622

Premarket Exempt : No

Product Code : BZL

Prescription Use : Yes

Device Count : 1

MGC Diagnostics - 00810016250210 Catalog Number : 800860-021

Device Description : Ultima System PFX CardiO2

Device Class : 2

Duns Number: 094045622

Premarket Exempt : No

Product Code : BZL

Prescription Use : Yes

Device Count : 1

MGC Diagnostics - 00810016250227 Catalog Number : 800860-031

Device Description : Ultima System PFX CardiO2 - 230V UPS

Device Class : 2

Duns Number: 094045622

Premarket Exempt : No

Product Code : BZL

Prescription Use : Yes

Device Count : 1

MGC Diagnostics - 00810016250234 Catalog Number : 830007-902

Device Description : Elite Platinum DL

Device Class : 2

Duns Number: 094045622

Premarket Exempt : No

Product Code : CCM

Prescription Use : Yes

Device Count : 1

MGC Diagnostics - 00810016250241 Catalog Number : 830008-902

Device Description : ELITE PLATINUM DX

Device Class : 2

Duns Number: 094045622

Premarket Exempt : No

Product Code : CCM

Prescription Use : Yes

Device Count : 1

MGC Diagnostics - 00810016250258 Catalog Number : 536713-001

Device Description : preVent Filter

Device Class : 2

Duns Number: 094045622

Premarket Exempt : No

Product Code : BZG

Prescription Use : Yes

Device Count : 1

MGC Diagnostics - 00810016250265 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 - 00810016250272 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

MCG Diagnostics - 00810016250289 Catalog Number : 536723-001

Device Description : FILTER KIT 2

Device Class : 2

Duns Number: 094045622

Premarket Exempt : No

Product Code : BZG

Prescription Use : Yes

Device Count : 1

MGC Diagnostics - 00810016250296 Catalog Number : 536713-005

Device Description : Filter for preVent Flow Sensor - Pediatric

Device Class : 2

Duns Number: 094045622

Premarket Exempt : No

Product Code : BZG

Prescription Use : Yes

Device Count : 1

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