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) (10)

Premarket Exempt

No Yes

Clear

CURAPLEX - 00612223300289 Catalog Number : 301-P3000H-S

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

Device Class : 2

Duns Number: 185432994

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

CURAPLEX - 00612223300296 Catalog Number : 301-P3000BH

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

Device Class :

Duns Number: 185432994

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

MISTIC - 00612223300357 Catalog Number : P3000NAL

Device Description : ENTRAINMENT NEBULIZER,BARREL STANDARD FLOW UP TO 12LPM, AIRLIFE FIT

Device Class : 2

Duns Number: 185432994

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

MISTIC - 00612223300364 Catalog Number : P3000HAL

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

Device Class : 2

Duns Number: 185432994

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

MISTIC - 00612223310158 Catalog Number : P3100N

Device Description : CLOSED DILUTION NEBULIZER,BARREL STANDARD FLOW UP TO 12LPM

Device Class : 2

Duns Number: 185432994

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

CURAPLEX - 00612223310165 Catalog Number : P3100NC

Device Description : CLOSED DILUTION NEBULIZER,BARREL STANDARD FLOW UP TO 12LPM

Device Class : 2

Duns Number: 185432994

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

RES-Q - 00612223310172 Catalog Number : P3100NA

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

Device Class : 2

Duns Number: 185432994

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

CURAPLEX RES-Q - 00612223310189 Catalog Number : P3100NAC

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

Device Class : 2

Duns Number: 185432994

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

CURAPLEX RES-Q - 00612223310196 Catalog Number : P3100NAKA

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

Device Class :

Duns Number: 185432994

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

MISTIC - 00612223310257 Catalog Number : P3100H

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

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