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) (10)

Premarket Exempt

No Yes

Clear

Phantom 2 Nasal Vented Mask - 00814747022801 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 3 Point Headgear - 00814747022849 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

iQ Blue Nasal Mask with iQ 3 Point Headgear - 00814747022856 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 - 00814747022863 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 Ventilation Mask & iQ 3 Point Headgear - 00814747022870 Catalog Number :

Device Description : Nasal non vented mask for use with positive pressure ventilators with exhalation valves.

Device Class : 2

Duns Number: 785635186

Premarket Exempt : Yes

Product Code : BZD

Prescription Use : Yes

Device Count : 1

iQ Blue Nasal Mask & 6" Tapered Tubing with iQ StableFit Headgear - 00814747022887 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

iQ Blue Ventilation Nasal Mask with iQ StableFit Headgear - 00814747022894 Catalog Number :

Device Description : Nasal non vented mask for use with CPAP/bilevel positive pressure systems with e Nasal non vented mask for use with CPAP/bilevel positive pressure systems with exhalation valves.

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 - 00814747022900 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 - 00814747022917 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

MiniMe Pediatric Mask with Headgear, Size Small - 00814747023020 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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