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

Ventilator, Non-Continuous (Respirator) (BZD) (4) Apparatus, Suction, Operating-Room, Wall Vacuum Powered (GCX) (2) Condenser, Heat And Moisture (Artificial Nose) (BYD) (1) Nebulizer (Direct Patient Interface) (CAF) (1)

Premarket Exempt

No Yes

Clear

Portable Suction Machine, Replacement Power Cord (without Adapter) - 00848530088989 Catalog Number : SU100DC-Cord

Device Description : Portable Suction Machine, Replacement Power Cord (without Adapter)

Device Class : 2

Duns Number: 141668116

Premarket Exempt : Yes

Product Code : GCX

Prescription Use : No

Device Count : 1

Suction Kit - 00848530088996 Catalog Number : RES026S-516TS

Device Description : This Kit Contains: 1 RES025 Suction Tubing 1/4in x 6ft, 1 RES024M Suction Tube C This Kit Contains: 1 RES025 Suction Tubing 1/4in x 6ft, 1 RES024M Suction Tube Connector 4.5in, 1 BF516TS Final Bacteria Filter, 1 RES023S Suction Canister.

Device Class :

Duns Number: 141668116

Premarket Exempt : Yes

Product Code :

Prescription Use : No

Device Count : 1

DeVilbiss 525 DS Kit - 00848530089009 Catalog Number : OF5004SP-1

Device Description : This kit contains: 1 OF5004 Foam Cabinet Filters, 1 BF1438 Final Bacteria Filter This kit contains: 1 OF5004 Foam Cabinet Filters, 1 BF1438 Final Bacteria Filter, 1 OF6011 Extended Life Bacteria Filter.

Device Class :

Duns Number: 141668116

Premarket Exempt : Yes

Product Code :

Prescription Use : No

Device Count : 1

3/16in Suction Tubing — 20in - 00848530089023 Catalog Number : RES025-31620

Device Description : 3/16in Suction Tubing — 20in

Device Class :

Duns Number: 141668116

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

3/16in Suction Tubing — 6ft - 00848530089030 Catalog Number : RES025-31672

Device Description : 3/16in Suction Tubing — 6ft

Device Class :

Duns Number: 141668116

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

3/16in Suction Tubing — 18in - 00848530089047 Catalog Number : RES025-31618

Device Description : 3/16in Suction Tubing — 18in

Device Class :

Duns Number: 141668116

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

Sunset Flex HME - 00848530089054 Catalog Number : RES027FLEX

Device Description : Sunset Flex HME

Device Class :

Duns Number: 141668116

Premarket Exempt : Yes

Product Code : BYD

Prescription Use : No

Device Count : 1

Drawstring Bag 13in x 12in - 00848530089061 Catalog Number : BAGDS1312

Device Description : Drawstring Bag 13in x 12in

Device Class :

Duns Number: 141668116

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

Drawstring Bags 10in x 10in - 00848530089078 Catalog Number : BAGDS1010

Device Description : Drawstring Bags 10in x 10in

Device Class :

Duns Number: 141668116

Premarket Exempt : Yes

Product Code : GCX

Prescription Use : No

Device Count : 50

Sunset Nebulizer w/ Disposable Adult Neb Kit & Reusable Adult Neb Kit - 00848530089146 Catalog Number : NEB100-R

Device Description : Sunset Nebulizer w/ Disposable Adult Neb Kit & Reusable Adult Neb Kit

Device Class : 2

Duns Number: 141668116

Premarket Exempt : No

Product Code : CAF

Prescription Use : Yes

Device Count : 1

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