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) Humidifier, Respiratory Gas, (Direct Patient Interface) (BTT) (2)

Premarket Exempt

No Yes

Clear

CURAPLEX - 00612223310264 Catalog Number : P3100HC

Device Description : CLOSED DILUTION NEBULIZER, HIGH FLOW, UP TO 40 LPM

Device Class : 2

Duns Number: 185432994

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

CURAPLEX - 00612223310271 Catalog Number : P3100HC-L

Device Description : CLOSED DILUTION NEBULIZER, HIGH FLOW, UP TO 40 LPM, LONG TUBE

Device Class : 2

Duns Number: 185432994

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

CURAPLEX RES-Q - 00612223310288 Catalog Number : P3100NAKP

Device Description : CONTINUOUS NEBULIZER KIT, STANDARD FLOW UP TO 12LPM, WITH PEDIATRIC MASK

Device Class : 2

Duns Number: 185432994

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

PACIFIC MEDICO - 00612223321024 Catalog Number : PMC-500M

Device Description : HUMIDIFICATION CHAMBER, 500ML, 20/CASE

Device Class :

Duns Number: 185432994

Premarket Exempt : Yes

Product Code : BTT

Prescription Use : Yes

Device Count : 1

PACIFIC MEDICO - 00612223321031 Catalog Number : PMC-300AF

Device Description : 300 ML DISPOSABLE HUMIDIFICATION CHAMBER, WITH AUTO FEED TUBING. 24/CASE

Device Class : 2

Duns Number: 185432994

Premarket Exempt : Yes

Product Code : BTT

Prescription Use : Yes

Device Count : 1

MISTIC - 00612223700058 Catalog Number : P7000

Device Description : NEBULIZER,BARREL REUSABLE BOTTLE 1000ML

Device Class : 2

Duns Number: 185432994

Premarket Exempt : No

Product Code : CAF

Prescription Use : No

Device Count : 1

PEGASUS - 00612223701017 Catalog Number : P70100

Device Description : NEBULIZER HEATER ADAPTER GASKET

Device Class : 2

Duns Number: 185432994

Premarket Exempt : No

Product Code : CAF

Prescription Use : No

Device Count : 1

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