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) (8) Apparatus, Suction, Operating-Room, Wall Vacuum Powered (GCX) (1) Apparatus, Suction, Ward Use, Portable, Ac-Powered (JCX) (1)

Premarket Exempt

No Yes

Clear

Nasal CPAP Mask — Medium - 00848530088866 Catalog Number : CM006MPL

Device Description : Includes 1 medium sized mask, with headgear and replaceable cushion.

Device Class : 2

Duns Number: 141668116

Premarket Exempt : No

Product Code : BZD

Prescription Use : No

Device Count : 1

Nasal CPAP Mask — Large - 00848530088873 Catalog Number : CM006LPL

Device Description : Includes 1 large sized mask, with headgear and replaceable cushion.

Device Class : 2

Duns Number: 141668116

Premarket Exempt : Yes

Product Code : BZD

Prescription Use : No

Device Count : 1

Nasal Pillow CPAP Mask - 00848530088880 Catalog Number : CM036PL

Device Description : Includes 1 mask frame with headgear and small, medium, and large pillows

Device Class : 2

Duns Number: 141668116

Premarket Exempt : No

Product Code : BZD

Prescription Use : No

Device Count : 1

Full Face CPAP Mask — Large - 00848530088897 Catalog Number : ASCM002CM005L

Device Description : Includes 1 mask with headgear and replaceable cushion.

Device Class : 2

Duns Number: 141668116

Premarket Exempt : Yes

Product Code : BZD

Prescription Use : No

Device Count : 1

Full Face CPAP Mask — Medium - 00848530088910 Catalog Number : ASCM002CM005M

Device Description : Includes 1 medium sized mask with headgear and replaceable cushion.

Device Class : 2

Duns Number: 141668116

Premarket Exempt : No

Product Code : BZD

Prescription Use : No

Device Count : 1

Full Face CPAP Mask — Small - 00848530088927 Catalog Number : ASCM002CM005S

Device Description : Includes 1 small sized mask with headgear and replaceable cushion.

Device Class : 2

Duns Number: 141668116

Premarket Exempt : Yes

Product Code : BZD

Prescription Use : No

Device Count : 1

Nasal CPAP Mask — Large - 00848530088934 Catalog Number : ASCM002CM006L

Device Description : Includes 1 large sized mask with headgear and replaceable cushion.

Device Class : 2

Duns Number: 141668116

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

Nasal CPAP Mask — Medium - 00848530088958 Catalog Number : ASCM002CM006M

Device Description : Includes 1 medium sized mask with headgear and replaceable cushion.

Device Class : 2

Duns Number: 141668116

Premarket Exempt : Yes

Product Code : BZD

Prescription Use : Yes

Device Count : 1

Portable Suction Machine - 00848530088965 Catalog Number : SU100DC

Device Description : Portable Suction Machine

Device Class :

Duns Number: 141668116

Premarket Exempt : No

Product Code : JCX

Prescription Use : No

Device Count : 1

Portable Suction Machine Replacement Power Adapter (without Cord) - 00848530088972 Catalog Number : SU100DC-Adapt

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

Device Class : 2

Duns Number: 141668116

Premarket Exempt : Yes

Product Code : GCX

Prescription Use : No

Device Count : 1

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