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

Unit, Filter, Membrane (JRL) (8) Apparatus, Suction, Operating-Room, Wall Vacuum Powered (GCX) (2)

Premarket Exempt

No Yes

Clear

Oxygen Tubing Y-Connector - 00848530003364 Catalog Number : AGISH749

Device Description : Oxygen Tubing Y-Connector (5/pack)

Device Class :

Duns Number: 141668116

Premarket Exempt : Yes

Product Code : GCX

Prescription Use : No

Device Count : 5

FILTER,HYDROPHOBIC, SET, BARB - 00848530003425 Catalog Number : AGIBF405

Device Description : Filter, Hydrophobic, Set, BARB

Device Class : 2

Duns Number: 141668116

Premarket Exempt : Yes

Product Code : GCX

Prescription Use : No

Device Count : 1

Plastic Intake Nebulizer Filters - with Heads - 00848530010102 Catalog Number : BF016

Device Description : Plastic Intake Nebulizer Filters - with Heads

Device Class :

Duns Number: 141668116

Premarket Exempt : Yes

Product Code : JRL

Prescription Use : No

Device Count : 10

Plastic Intake Nebulizer Filter - with Head - 00848530010119 Catalog Number : BF016-1

Device Description : Sunset Healthcare Solutions Plastic Intake Nebulizer Filter - with Head

Device Class : 1

Duns Number: 141668116

Premarket Exempt : Yes

Product Code : JRL

Prescription Use : No

Device Count : 1

Plastic Intake Nebulizer Filters - with Heads - 00848530010126 Catalog Number : BF016-5

Device Description : Plastic Intake Nebulizer Filters - with Heads

Device Class :

Duns Number: 141668116

Premarket Exempt : Yes

Product Code : JRL

Prescription Use : No

Device Count : 5

Plastic Intake Nebulizer Filters - with Heads - 00848530010140 Catalog Number : BF017

Device Description : Plastic Intake Nebulizer Filters - with Heads

Device Class :

Duns Number: 141668116

Premarket Exempt : Yes

Product Code : JRL

Prescription Use : No

Device Count : 5

Plastic Intake Nebulizer Filter - with Head - 00848530010157 Catalog Number : BF017-1

Device Description : Plastic Intake Nebulizer Filter - with Head

Device Class : 1

Duns Number: 141668116

Premarket Exempt : Yes

Product Code : JRL

Prescription Use : No

Device Count : 1

Plastic Intake Nebulizer Filters - with Head - 00848530010164 Catalog Number : BF017-2

Device Description : Plastic Intake Nebulizer Filters - with Head (2/pack)

Device Class :

Duns Number: 141668116

Premarket Exempt : Yes

Product Code : JRL

Prescription Use : No

Device Count : 2

Foam Nebulizer Filters - 00848530010188 Catalog Number : BF018

Device Description : Foam Nebulizer Filters (10/pack)

Device Class :

Duns Number: 141668116

Premarket Exempt : Yes

Product Code : JRL

Prescription Use : No

Device Count : 10

Foam Nebulizer Filter - 00848530010195 Catalog Number : BF018-1

Device Description : Foam Nebulizer Filter

Device Class : 1

Duns Number: 141668116

Premarket Exempt : Yes

Product Code : JRL

Prescription Use : No

Device Count : 1

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