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) (5) Mask, Oxygen, Low Concentration, Venturi (BYF) (4) Humidifier, Respiratory Gas, (Direct Patient Interface) (BTT) (1)

Premarket Exempt

No Yes

Clear

CURAPLEX - 00612223030285 Catalog Number : P3000HCC-S

Device Description : CURAPLEX ENTRAINMENT NEBULIZER, HIGH FLOW, SHORT TUBE, UP TO 40 LPM, AIRLIFE FIT

Device Class : 2

Duns Number: 185432994

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

CURAPLEX - 00612223030315 Catalog Number : P3000NB

Device Description : ENTRAINMENT NEBULIZER,BARREL STANDARD FLOW UP TO 12LPM AND 500ML BOTTLE COMBINATION

Device Class : 2

Duns Number: 185432994

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

CURAPLEX - 00612223030339 Catalog Number : P3000HB

Device Description : CURAPLEX ENTRAINMENT NEBULIZER, HIGH FLOW, UP TO 40 LPM, WITH 500ML BOTTLE COMBINATION

Device Class : 2

Duns Number: 185432994

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

CURAPLEX - 00612223030353 Catalog Number : P3000CD

Device Description : CLOSED DILUTION NEBULIZER,BARREL STANDARD FLOW UP TO 12LPM, WITH 500ML BOTTLE COMBINATION

Device Class : 2

Duns Number: 185432994

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

MISTIC - 00612223035013 Catalog Number : P3500

Device Description : HUMIDIFIER

Device Class : 2

Duns Number: 185432994

Premarket Exempt : No

Product Code : BTT

Prescription Use : Yes

Device Count : 1

THERMAGARD - 00612223057053 Catalog Number : P20001H

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

PEGASUS - 00612223060015 Catalog Number : P6000

Device Description : FLO2 HIGH FLOW OXYGEN DILUTER, ADULT KIT

Device Class : 1

Duns Number: 185432994

Premarket Exempt : Yes

Product Code : BYF

Prescription Use : Yes

Device Count : 1

PEGASUS - 00612223060510 Catalog Number : P6050

Device Description : FLO2 HIGH FLOW OXYGEN DILUTER

Device Class : 1

Duns Number: 185432994

Premarket Exempt : Yes

Product Code : BYF

Prescription Use : Yes

Device Count : 1

PEGASUS - 00612223061012 Catalog Number : P6100

Device Description : FLO2 HIGH FLOW OXYGEN DILUTER, PEDIATRIC KIT

Device Class : 1

Duns Number: 185432994

Premarket Exempt : Yes

Product Code : BYF

Prescription Use : Yes

Device Count : 1

PEGASUS - 00612223062019 Catalog Number : P6200

Device Description : FLO2 STANDARD FLOW OXYGEN DILUTER, ADULT KIT

Device Class : 1

Duns Number: 185432994

Premarket Exempt : Yes

Product Code : BYF

Prescription Use : Yes

Device Count : 1

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