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

Yes No

Clear

MiniMe Pediatric Mask with Headgear, Size Large - 00814747020906 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 - 00814747020913 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 - 00814747020920 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 - 00814747020937 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 2 Pediatric Nasal Vented Mask, S/M - 00814747020944 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 2 Pediatric Nasal Vented Mask, M/L - 00814747020951 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 2 Pediatric Nasal Vented Mask, S/M - 00814747020968 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 2 Pediatric Nasal Vented Mask, M/L - 00814747020975 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 2 Pediatric Nasal Non Vented Mask, S/M - 00814747020982 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 2 Pediatric Nasal Non Vented Mask, M/L - 00814747020999 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

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