CIRCADIANCE, LLC

Address:1010 Corporate Lane,Export,PA,15632,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

Clear

SleepWeaver Elan - Mask Only - Large - Leopard - B036100667 Catalog Number : 100667

Device Description : SleepWeaver Elan Cloth Nasal PAP Mask Only - Large - Leopard

Device Class : 2

Duns Number: 012721295

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

SleepWeaver Elan - Mask & Headgear - Small - Beige - B036100727 Catalog Number : 100727

Device Description : SleepWeaver Elan Cloth Nasal PAP Mask & Headgear - Small - Beige

Device Class : 2

Duns Number: 012721295

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

SleepWeaver Elan - Mask & Headgear - Small - Blue - B036100728 Catalog Number : 100728

Device Description : SleepWeaver Elan Cloth Nasal PAP Mask & Headgear - Small - Blue

Device Class : 2

Duns Number: 012721295

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

SleepWeaver Elan - Mask & Headgear - Small - Pink - B036100729 Catalog Number : 100729

Device Description : SleepWeaver Elan Cloth Nasal PAP Mask & Headgear - Small - Pink

Device Class : 2

Duns Number: 012721295

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

SleepWeaver Elan - Mask & Headgear - Small - Camo - B036100730 Catalog Number : 100730

Device Description : SleepWeaver Elan Cloth Nasal PAP Mask & Headgear - Small - Camo

Device Class : 2

Duns Number: 012721295

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

SleepWeaver Elan - Mask & Headgear - Small - Leopard - B036100731 Catalog Number : 100731

Device Description : SleepWeaver Elan Cloth Nasal PAP Mask & Headgear - Small - Leopard

Device Class : 2

Duns Number: 012721295

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

SleepWeaver Elan - Mask Only - Small - Beige - B036100742 Catalog Number : 100742

Device Description : SleepWeaver Elan Cloth Nasal PAP Mask Only - Small - Beige

Device Class : 2

Duns Number: 012721295

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

SleepWeaver Elan - Mask Only - Small - Blue - B036100743 Catalog Number : 100743

Device Description : SleepWeaver Elan Cloth Nasal PAP Mask Only - Small - Blue

Device Class : 2

Duns Number: 012721295

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

SleepWeaver Elan - Mask Only - Small - Pink - B036100744 Catalog Number : 100744

Device Description : SleepWeaver Elan Cloth Nasal PAP Mask Only - Small - Pink

Device Class : 2

Duns Number: 012721295

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

SleepWeaver Elan - Mask Only - Small - Camo - B036100745 Catalog Number : 100745

Device Description : SleepWeaver Elan Cloth Nasal PAP Mask Only - Small - Camo

Device Class : 2

Duns Number: 012721295

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

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