SLEEPNET, CORP.

Address:5 MERRILL INDUSTRIAL DRIVE,Hampton,NH,03842,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) (7) Mask, Oxygen (BYG) (3)

Premarket Exempt

Yes No

Clear

Innova Nasal Non Vented Mask, m/l - 00814747020807 Catalog Number :

Device Description : Nasal non vented mask for use with non invasive ventilator system with exhalation valves.

Device Class : 1

Duns Number: 785635186

Premarket Exempt : Yes

Product Code : BYG

Prescription Use : Yes

Device Count : 1

Innova Hospital Nasal Non Vented Mask, s/m - 00814747020814 Catalog Number :

Device Description : Disposable nasal non vented mask for use with non invasive ventilator system wit Disposable nasal non vented mask for use with non invasive ventilator system with exhalation valves.

Device Class : 1

Duns Number: 785635186

Premarket Exempt : Yes

Product Code : BYG

Prescription Use : Yes

Device Count : 1

Innova Hospital Nasal Non Vented Mask, m/l - 00814747020821 Catalog Number :

Device Class : 1

Duns Number: 785635186

Premarket Exempt : Yes

Product Code : BYG

Prescription Use : Yes

Device Count : 1

iQ Blue Nasal Mask with iQ 3 Point Headgear - 00814747020838 Catalog Number :

Device Description : Nasal vented mask for use in positive pressure ventilation.

Device Class : 2

Duns Number: 785635186

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

iQ Blue Nasal Mask with iQ 3 Point Headgear - 00814747020845 Catalog Number :

Device Description : Nasal vented mask for use in positive pressure ventilation.

Device Class : 2

Duns Number: 785635186

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

iQ Blue Nasal Mask with iQ StableFit Headgear - 00814747020852 Catalog Number :

Device Description : Nasal vented mask for use in positive pressure ventilation.

Device Class : 2

Duns Number: 785635186

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

iQ Blue Nasal Mask with iQ StableFit Headgear - 00814747020869 Catalog Number :

Device Description : Nasal vented mask for use in positive pressure ventilation.

Device Class : 2

Duns Number: 785635186

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

iQ Blue Nasal Mask & 6" Tapered Tubing with iQ StableFit Headgear - 00814747020876 Catalog Number :

Device Description : Nasal vented mask for use with positive pressure ventilation.

Device Class : 2

Duns Number: 785635186

Premarket Exempt : Yes

Product Code : BZD

Prescription Use : Yes

Device Count : 1

MiniMe Pediatric Mask with Headgear, Size Small - 00814747020883 Catalog Number :

Device Description : Pediatric nasal vented mask for use in positive pressure ventilation.

Device Class : 2

Duns Number: 785635186

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

MiniMe Pediatric Mask with Headgear, Size Medium - 00814747020890 Catalog Number :

Device Description : Pediatric nasal vented mask for use in positive pressure ventilation.

Device Class : 2

Duns Number: 785635186

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

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