PEGASUS RESEARCH CORPORATION

Address:1518 E Edinger Ave Ste A,Santa Ana,CA,92705,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

Nebulizer (Direct Patient Interface) (CAF) (8) Mask, Oxygen, Low Concentration, Venturi (BYF) (2)

Premarket Exempt

No Yes

Clear

PEGASUS - 00612223062514 Catalog Number : P6250

Device Description : FLO2 STANDARD FLOW OXYGEN DILUTER

Device Class : 1

Duns Number: 185432994

Premarket Exempt : Yes

Product Code : BYF

Prescription Use : Yes

Device Count : 1

PEGASUS - 00612223063016 Catalog Number : P6300

Device Description : FLO2 STANDARD FLOW OXYGEN DILUTER, PEDIATRIC KIT

Device Class : 1

Duns Number: 185432994

Premarket Exempt : Yes

Product Code : BYF

Prescription Use : Yes

Device Count : 1

PEGASUS - 00612223200015 Catalog Number : P2001

Device Description : NEBULIZING SYSTEM HEATING ELEMENT AND ADAPTER

Device Class : 2

Duns Number: 185432994

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

CURAPLEX - 00612223200114 Catalog Number : P2001C

Device Description : NEBULIZING SYSTEM HEATING ELEMENT AND ADAPTER

Device Class : 2

Duns Number: 185432994

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

CURAPLEX - 00612223200121 Catalog Number : P2001CC

Device Description : NEBULIZING SYSTEM HEATING ELEMENT AND ADAPTER, AIRLIFE FIT

Device Class : 2

Duns Number: 185432994

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

PEGASUS - 00612223230005 Catalog Number : P23000

Device Description : HUMIDIFIER HEATER BRACKET

Device Class : 2

Duns Number: 185432994

Premarket Exempt : No

Product Code : CAF

Prescription Use : No

Device Count : 1

PEGASUS - 00612223230012 Catalog Number : P23001

Device Description : HUMIDIFIER HEATER BRACKET, VISION/PHILIPSV60 FIT

Device Class : 2

Duns Number: 185432994

Premarket Exempt : No

Product Code : CAF

Prescription Use : No

Device Count : 1

PEGASUS - 00612223260002 Catalog Number : P26000

Device Description : CURAPLEX HEATER CORE FOR 301-P2000

Device Class : 2

Duns Number: 185432994

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

CURAPLEX - 00612223260019 Catalog Number : P26000C

Device Description : CURAPLEX HEATER CORE FOR 301-P2000

Device Class : 2

Duns Number: 185432994

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

CURAPLEX - 00612223260026 Catalog Number : P26020C

Device Description : CURAPLEX HEATER CORE FOR 301-P2000, AIR LIFE FIT

Device Class : 2

Duns Number: 185432994

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

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