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

MiniMe Pediatric Mask with Headgear, Size Medium - 00814747023037 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 Large - 00814747023044 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 Ventilation Mask with Headgear, Size Small - 00814747023051 Catalog Number :

Device Description : Pediatric nasal non 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 Ventilation Mask with Headgear, Size Medium - 00814747023068 Catalog Number :

Device Description : Pediatric nasal non 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 Ventilation Mask with Headgear, Size Large - 00814747023075 Catalog Number :

Device Description : Pediatric nasal non 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

FitStar Hospital Nasal Vented Mask, s/m - 00814747023082 Catalog Number :

Device Description : Disposable 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

FitStar Hospital Nasal Vented Mask, m/l - 00814747023099 Catalog Number :

Device Description : Disposable 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

FitStar Hospital Nasal Non Vented Mask, s/m - 00814747023105 Catalog Number :

Device Description : Disposable nasal non vented mask for use with CPAP/bilevel positive pressure sys

Device Class : 2

Duns Number: 785635186

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

FitStar Hospital Nasal Non Vented Mask, m/l - 00814747023112 Catalog Number :

Device Description : Disposable nasal non vented mask for use with CPAP/bilevel positive pressure sys

Device Class : 2

Duns Number: 785635186

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

Veraseal 2 Full Face Vented Mask, Extra Large - 10814747020118 Catalog Number :

Device Description : Disposable full face 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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