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) (7) Filter, Bacterial, Breathing-Circuit (CAH) (3)

Premarket Exempt

No Yes

Clear

EverFlo Intake Filter - 00848530010348 Catalog Number : BF1001

Device Description : EverFlo Intake Filter

Device Class : 1

Duns Number: 141668116

Premarket Exempt : Yes

Product Code : JRL

Prescription Use : No

Device Count : 1

Final Bacteria Filters — 1/4in to 1/2in - 00848530010386 Catalog Number : BF1412

Device Description : Final Bacteria Filters — 1/4in to 1/2in

Device Class :

Duns Number: 141668116

Premarket Exempt : Yes

Product Code : JRL

Prescription Use : No

Device Count : 10

Final Bacteria Filters - 1/4in to 3/8in - 00848530010409 Catalog Number : BF1438

Device Description : Final Bacteria Filters - 1/4in to 3/8in

Device Class :

Duns Number: 141668116

Premarket Exempt : Yes

Product Code : JRL

Prescription Use : No

Device Count : 10

Final Bacteria Filter - 1/4in to 3/8in - 00848530010416 Catalog Number : BF1438-1

Device Description : Final Bacteria Filter - 1/4in to 3/8in

Device Class : 1

Duns Number: 141668116

Premarket Exempt : Yes

Product Code : JRL

Prescription Use : Yes

Device Count : 1

Sunset Healthcare Solutions CPAP Final Bacteria/Viral Filter - 5/Pack - 00848530010454 Catalog Number : BF2200

Device Description : Sunset Healthcare Solutions CPAP Final Bacteria/Viral Filter - 5/Pack

Device Class :

Duns Number: 141668116

Premarket Exempt : No

Product Code : CAH

Prescription Use : No

Device Count : 5

Sunset Healthcare Solutions CPAP Final Bacteria/Viral Filter - 1/Pack - 00848530010461 Catalog Number : BF2200-1

Device Description : Sunset Healthcare Solutions CPAP Final Bacteria/Viral Filter - 1/Pack

Device Class : 2

Duns Number: 141668116

Premarket Exempt : No

Product Code : CAH

Prescription Use : No

Device Count : 1

Sunset Healthcare Solutions CPAP Final Bacteria/Viral Filter - 3/Pack - 00848530010478 Catalog Number : BF2200-3

Device Description : Sunset Healthcare Solutions CPAP Final Bacteria/Viral Filter - 3/Pack

Device Class :

Duns Number: 141668116

Premarket Exempt : No

Product Code : CAH

Prescription Use : No

Device Count : 3

Intake Bacteria Filters - 00848530010492 Catalog Number : BF2222

Device Description : Intake Bacteria Filters (5/pack)

Device Class :

Duns Number: 141668116

Premarket Exempt : Yes

Product Code : JRL

Prescription Use : No

Device Count : 5

Intake Bacteria Filter - 00848530010508 Catalog Number : BF2222-1

Device Description : Intake Bacteria Filter

Device Class : 1

Duns Number: 141668116

Premarket Exempt : Yes

Product Code : JRL

Prescription Use : No

Device Count : 1

Final Bacteria Filter - 3/16in - 00848530010522 Catalog Number : BF316

Device Description : Final Bacteria Filter - 3/16in (10/pack)

Device Class :

Duns Number: 141668116

Premarket Exempt : Yes

Product Code : JRL

Prescription Use : No

Device Count : 10

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