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

Apparatus, Suction, Operating-Room, Wall Vacuum Powered (GCX) (3) Filter, Bacterial, Breathing-Circuit (CAH) (1) Ventilator, Non-Continuous (Respirator) (BZD) (1)

Premarket Exempt

No Yes

Clear

Millennium Kit - 00848530000097 Catalog Number : ACHE001MILKIT

Device Description : This kit contains: 1 OF1001 Foam Cabinet Filter, 1 BF2222 Intake Bacteria Filter This kit contains: 1 OF1001 Foam Cabinet Filter, 1 BF2222 Intake Bacteria Filter, 1 OF3003 Foam Intake FIlter.

Device Class :

Duns Number: 141668116

Premarket Exempt : Yes

Product Code :

Prescription Use : No

Device Count : 1

Christmas Tree Nut and Nipple Adaptor - 00848530000660 Catalog Number : HCS4555

Device Description : Christmas Tree Nut and Nipple Adaptor (50/pack)

Device Class :

Duns Number: 141668116

Premarket Exempt : Yes

Product Code : GCX

Prescription Use : No

Device Count : 50

Adapter, Straight 22mm O/D - 15mm I/D - 00848530000684 Catalog Number : HSK962A

Device Description : Adapter, Straight 22mm O/D - 15mm I/D (50/pack)

Device Class :

Duns Number: 141668116

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 50

Adapter, Pressure Line O2 Treatment - 00848530000707 Catalog Number : HCS1642

Device Description : Adapter, Pressure Line O2 Treatment (50 adapters)

Device Class :

Duns Number: 141668116

Premarket Exempt : Yes

Product Code : GCX

Prescription Use : No

Device Count : 50

Cylinder Wrenches for Post Valve - 00848530000714 Catalog Number : AMED014RES032

Device Description : Cylinder Wrenches for Post Valve (50 wrenches)

Device Class :

Duns Number: 141668116

Premarket Exempt : Yes

Product Code :

Prescription Use : No

Device Count : 50

FILTER,HYDOPHOBIC, SET,BARB 3/PK - 00848530000905 Catalog Number : SUHBF4053

Device Description : FILTER,HYDOPHOBIC, SET, BARB 3/PK

Device Class :

Duns Number: 141668116

Premarket Exempt : Yes

Product Code : CAH

Prescription Use : No

Device Count : 3

Washers with Rubber Ring - Brass - 00848530001162 Catalog Number : HCS166840

Device Description : Washers with Rubber Ring - Brass (50 Washers)

Device Class :

Duns Number: 141668116

Premarket Exempt : Yes

Product Code : GCX

Prescription Use : No

Device Count : 50

Millennium Kit - 00848530001193 Catalog Number : ATRI006MILKIT

Device Description : This kit contains: 2 OF1001 Foam Cabinet Filters, 1 BF2222 Intake Bacteria Filte This kit contains: 2 OF1001 Foam Cabinet Filters, 1 BF2222 Intake Bacteria Filter, 1 OF3003 Foam Intake Filter.

Device Class :

Duns Number: 141668116

Premarket Exempt : Yes

Product Code :

Prescription Use : No

Device Count : 1

Suction Kit - 00848530001308 Catalog Number : ATOW001RES026

Device Description : This kit contains: 1 RES025 Suction Tubing — 6ft, 1 RES024 Suctions Tubing Conne This kit contains: 1 RES025 Suction Tubing — 6ft, 1 RES024 Suctions Tubing Connector - 3.5in, 1 RES023 Suction Canister, 1 BF516TS Bacteria Filter Suction.

Device Class :

Duns Number: 141668116

Premarket Exempt : Yes

Product Code :

Prescription Use : No

Device Count : 1

Tabbed Cannula with 7ft Supply Tube - 00848530003166 Catalog Number : ACOR002RES1007V

Device Description : Tabbed Cannula with 7ft Supply Tube (1/pack)

Device Class :

Duns Number: 141668116

Premarket Exempt : Yes

Product Code :

Prescription Use : No

Device Count : 1

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