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 Advance - Mask & Headgear - Blue - B036100274 Catalog Number : 100274

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

Device Class : 2

Duns Number: 012721295

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

SleepWeaver Advance - Mask & Headgear - Pink - B036100277 Catalog Number : 100277

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

Device Class : 2

Duns Number: 012721295

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

SleepWeaver Advance - Mask & Headgear - Camo - B036100281 Catalog Number : 100281

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

Device Class : 2

Duns Number: 012721295

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

SleepWeaver Advance - Mask & Headgear - Leopard - B036100285 Catalog Number : 100285

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

Device Class : 2

Duns Number: 012721295

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

SleepWeaver Advance - Mask Only - Blue - B036100289 Catalog Number : 100289

Device Description : SleepWeaver Advance Cloth Nasal CPAP Mask Only - Blue

Device Class : 2

Duns Number: 012721295

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

SleepWeaver Advance - Mask Only - Pink - B036100291 Catalog Number : 100291

Device Description : SleepWeaver Advance Cloth Nasal CPAP Mask Only - Pink

Device Class : 2

Duns Number: 012721295

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

SleepWeaver Advance - Mask Only - Camo - B036100293 Catalog Number : 100293

Device Description : SleepWeaver Advance Cloth Nasal CPAP Mask Only - Camo

Device Class : 2

Duns Number: 012721295

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

SleepWeaver Advance - Mask Only - Leopard - B036100295 Catalog Number : 100295

Device Description : SleepWeaver Advance Cloth Nasal CPAP Mask Only - Leopard

Device Class : 2

Duns Number: 012721295

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

SleepWeaver Advance - Mask & Headgear - Beige - B036100332 Catalog Number : 100332

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

Device Class : 2

Duns Number: 012721295

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

SleepWeaver Advance - Mask Only - Beige - B036100336 Catalog Number : 100336

Device Description : SleepWeaver Advance Cloth Nasal CPAP Mask Only - Beige

Device Class : 2

Duns Number: 012721295

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

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