SUNSET HEALTHCARE SOLUTIONS, INC.

Address:180 N Michigan Ave Ste 2000,CHICAGO,IL,60601,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

Disinfector, Medical Devices (MEC) (1) Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer (BZE) (1) Nebulizer (Direct Patient Interface) (CAF) (1)

Premarket Exempt

No Yes

Clear

Oxygen Kit - 00848530090319 Catalog Number : APEN002O2KIT

Device Description : APEN002O2KIT: This oxygen kit contains: (26) RES1107S (2) RES018 (2) RES3025G ( APEN002O2KIT: This oxygen kit contains: (26) RES1107S (2) RES018 (2) RES3025G (1) RES003 (1) RES035 (1) RES032

Device Class :

Duns Number: 141668116

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

Heated CPAP Tube - 00848530090609 Catalog Number :

Device Description : HEATER, BREATHING SYSTEM W/WO CONTROLLER (NOT HUMIDIFIER OR NEBULIZER)

Device Class : 2

Duns Number: 141668116

Premarket Exempt : No

Product Code : BZE

Prescription Use : Yes

Device Count : 1

Zoey CPAP Cleaner - 00848530090890 Catalog Number : ZCD100

Device Description : CPAP Cleaning Device

Device Class : 2

Duns Number: 141668116

Premarket Exempt : Yes

Product Code : MEC

Prescription Use : No

Device Count : 1

Sunset Handheld Mesh Nebulizer - 00848530098537 Catalog Number :

Device Description : The device is a Vibrating Mesh Nebulizer System that designed to aerosolize liqu The device is a Vibrating Mesh Nebulizer System that designed to aerosolize liquid medication for inhalation therapy by the patient.

Device Class : 2

Duns Number: 141668116

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

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