POM MEDICAL, LLC

Address:5456 Endeavor Court,Moorpark,CA,93021,US

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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

Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase (CCK) (6) Mask, Oxygen (BYG) (4)

Premarket Exempt

No Yes

Clear

POM - 10851438008000 Catalog Number :

Device Description : Adult High Concentration Procedural Oxygen Mask

Device Class : 1

Duns Number: 078731530

Premarket Exempt : Yes

Product Code : BYG

Prescription Use : Yes

Device Count : 1

Pedi-POM - 10851438008017 Catalog Number :

Device Description : Pediatric High Concentration Procedural Oxygen Mask

Device Class : 1

Duns Number: 078731530

Premarket Exempt : Yes

Product Code : BYG

Prescription Use : Yes

Device Count : 1

POM Elite MM - 10851438008024 Catalog Number :

Device Description : Adult Procedural Oxygen Mask with High & Medium Concentration & CO2 Monitoring ( Adult Procedural Oxygen Mask with High & Medium Concentration & CO2 Monitoring (Male to Male)

Device Class : 2

Duns Number: 078731530

Premarket Exempt : No

Product Code : CCK

Prescription Use : Yes

Device Count : 1

POM Elite MF - 10851438008031 Catalog Number :

Device Description : Adult Procedural Oxygen Mask with High & Medium Concentration & CO2 Monitoring Adult Procedural Oxygen Mask with High & Medium Concentration & CO2 Monitoring (Male to Female)

Device Class : 2

Duns Number: 078731530

Premarket Exempt : No

Product Code : CCK

Prescription Use : Yes

Device Count : 1

POM Elite MSA - 10851438008048 Catalog Number :

Device Description : Adult Procedural Oxygen Mask with High & Medium Concentration & CO2 Monitoring Adult Procedural Oxygen Mask with High & Medium Concentration & CO2 Monitoring (Microstream™ Compatible)

Device Class : 2

Duns Number: 078731530

Premarket Exempt : No

Product Code : CCK

Prescription Use : Yes

Device Count : 1

Pedi-POM Elite MM - 10851438008055 Catalog Number :

Device Description : Pediatric Procedural Oxygen Mask with High & Medium Concentration & CO2 Monitori Pediatric Procedural Oxygen Mask with High & Medium Concentration & CO2 Monitoring (Male to Male)

Device Class : 2

Duns Number: 078731530

Premarket Exempt : No

Product Code : CCK

Prescription Use : Yes

Device Count : 1

Pedi-POM Elite MF - 10851438008062 Catalog Number :

Device Description : Pediatric Procedural Oxygen Mask with High & Medium Concentration & CO2 Monitori Pediatric Procedural Oxygen Mask with High & Medium Concentration & CO2 Monitoring (Male to Female)

Device Class : 2

Duns Number: 078731530

Premarket Exempt : No

Product Code : CCK

Prescription Use : Yes

Device Count : 1

Pedi-POM Elite MSA - 10851438008079 Catalog Number :

Device Class : 2

Duns Number: 078731530

Premarket Exempt : No

Product Code : CCK

Prescription Use : Yes

Device Count : 1

POM EZ-Lite - 10851438008086 Catalog Number :

Device Description : Adult Procedural Oxygen Mask - Medium Concentration

Device Class : 1

Duns Number: 078731530

Premarket Exempt : Yes

Product Code : BYG

Prescription Use : Yes

Device Count : 1

Pedi-POM EZ-Lite - 10851438008093 Catalog Number :

Device Description : Pediatric Procedural Oxygen Mask - Medium Concentration

Device Class : 1

Duns Number: 078731530

Premarket Exempt : Yes

Product Code : BYG

Prescription Use : Yes

Device Count : 1

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