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 - Small - Leopard - B036100746 Catalog Number : 100746

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

Device Class : 2

Duns Number: 012721295

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

SleepWeaver Elan - Mask & Headgear Starter Kit - Blue - B036100782 Catalog Number : 100782

Device Description : SleepWeaver Elan Cloth Nasal PAP Mask & Headgear Start Kit - Small/Regular/Large SleepWeaver Elan Cloth Nasal PAP Mask & Headgear Start Kit - Small/Regular/Large Cushions - Blue

Device Class : 2

Duns Number: 012721295

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

SleepWeaver Anew - Mask & Headgear - Small - Blue - B036100954 Catalog Number : 100954

Device Description : SleepWeaver Anew Cloth Full Face PAP Mask & Headgear - Small - Blue

Device Class : 2

Duns Number: 012721295

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

SleepWeaver Anew - Mask & Headgear - Regular - Blue - B036100960 Catalog Number : 100960

Device Description : SleepWeaver Anew Cloth Full Face PAP Mask & Headgear - Regular - Blue

Device Class : 2

Duns Number: 012721295

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

SleepWeaver Anew - Mask & Headgear - Large - Beige - B036100964 Catalog Number : 100964

Device Description : SleepWeaver Anew Cloth Full Face PAP Mask & Headgear - Large - Beige

Device Class : 2

Duns Number: 012721295

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

SleepWeaver Anew - Mask & Headgear - Large - Blue - B036100965 Catalog Number : 100965

Device Description : SleepWeaver Anew Cloth Full Face PAP Mask & Headgear - Large - Blue

Device Class : 2

Duns Number: 012721295

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

SleepWeaver Anew - Mask Only - Small - Blue - B036100970 Catalog Number : 100970

Device Description : SleepWeaver Anew Cloth Full Face PAP Mask Only - Small - Blue

Device Class : 2

Duns Number: 012721295

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

SleepWeaver Anew - Mask Only - Regular - Blue - B036100975 Catalog Number : 100975

Device Description : SleepWeaver Anew Cloth Full Face PAP Mask Only - Regular - Blue

Device Class : 2

Duns Number: 012721295

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

SleepWeaver Anew - Mask Only - Large - Blue - B036100980 Catalog Number : 100980

Device Description : SleepWeaver Anew Cloth Full Face PAP Mask Only - Large - Blue

Device Class : 2

Duns Number: 012721295

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

SleepWeaver Advance Small - Mask & Headgear - Beige - B036101224 Catalog Number : 101224

Device Description : SleepWeaver Advance Small Cloth Nasal CPAP Mask & Headgear - Biege

Device Class : 2

Duns Number: 012721295

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

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