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) (7) Humidifier, Respiratory Gas, (Direct Patient Interface) (BTT) (3)

Premarket Exempt

No Yes

Clear

CURAPLEX - 00612223001322 Catalog Number : P3500C

Device Description : WICK HUMIDIFIER

Device Class : 2

Duns Number: 185432994

Premarket Exempt : No

Product Code : BTT

Prescription Use : Yes

Device Count : 1

CURAPLEX - 00612223001346 Catalog Number : P3500SC

Device Description : ENTRAINMENT WICK HUMIDIFIER

Device Class : 2

Duns Number: 185432994

Premarket Exempt : No

Product Code : BTT

Prescription Use : Yes

Device Count : 1

CURAPLEX - 00612223013202 Catalog Number : P3500CC

Device Description : WICK HUMIDIFIER, AIRLIFE FIT

Device Class : 2

Duns Number: 185432994

Premarket Exempt : No

Product Code : BTT

Prescription Use : Yes

Device Count : 1

CURAPLEX - 00612223020002 Catalog Number : P2000C

Device Description : CURAPLEX HUMIDIFIER HEATER, 115V

Device Class : 2

Duns Number: 185432994

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

CURAPLEX - 00612223030117 Catalog Number : P3000NCC

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

CURAPLEX - 00612223030131 Catalog Number : P3000NCC-L

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

Device Class : 2

Duns Number: 185432994

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

CURAPLEX - 00612223030155 Catalog Number : P3000NCC-S

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

Device Class : 2

Duns Number: 185432994

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

MISTIC - 00612223030223 Catalog Number : P3000H-CAN

Device Description : ENTRAINMENT NEBULIZER WITH GASKET, HIGH FLOW, UP TO 40 LPM, SAP CANADA,

Device Class : 2

Duns Number: 185432994

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

CURAPLEX - 00612223030247 Catalog Number : P3000HCC

Device Description : CURAPLEX 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

CURAPLEX - 00612223030261 Catalog Number : P3000HCC-L

Device Description : CURAPLEX ENTRAINMENT NEBULIZER, HIGH FLOW, LONG 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

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