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

Ascend Full Face Vented Mask with Multi-Size Cushions - 00814747022412 Catalog Number :

Device Description : 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

Ascend Nasal Vented Mask with Multi-Size Cushions - 00814747022429 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

Ascend Nasal Vented Mask, Small - 00814747022436 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

Ascend Nasal Vented Mask, Large - 00814747022443 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

Ascend Nasal Vented Mask, Medium - 00814747022450 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

Ascend Nasal Vented Mask, Small - 00814747022467 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

Ascend Nasal Mask System - 00814747022474 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

Ascend Full Face Vented Mask, Small - 00814747022481 Catalog Number :

Device Description : 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

Ascend Full Face Vented Mask, Medium - 00814747022498 Catalog Number :

Device Description : 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

Ascend Full Face Vented Mask System - 00814747022504 Catalog Number :

Device Description : 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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