CIRCADIANCE, LLC

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

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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) (5) Electrode, Electrocardiograph (DRX) (2) Monitor, Apnea, Home Use (NPF) (2) Oximeter (DQA) (2) Monitor, Breathing Frequency (BZQ) (1)

Premarket Exempt

Clear

Synergy E - B036101483 Catalog Number : 101483

Device Description : Synergy E Host Software for SmartMonitor 2 Product Line

Device Class : 2

Duns Number: 012721295

Premarket Exempt : No

Product Code : BZQ

Prescription Use : Yes

Device Count : 1

SleepWeaver 3D Mask and Regular Headgear - Blue - B036101486 Catalog Number : 101486

Device Description : SleepWeaver 3D Mask and Regular Headgear - Blue

Device Class : 2

Duns Number: 012721295

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

SleepWeaver 3D Mask and Large Headgear - Blue - B036101491 Catalog Number : 101491

Device Description : SleepWeaver 3D Mask and Large Headgear - Blue

Device Class : 2

Duns Number: 012721295

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

SleepWeaver 3D Mask only - Blue - B036101496 Catalog Number : 101496

Device Description : SleepWeaver 3D Mask only - Blue

Device Class : 2

Duns Number: 012721295

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

SleepWeaver 3D Regular Headgear only - B036101516 Catalog Number : 101516

Device Description : SleepWeaver 3D Regular Headgear only

Device Class : 2

Duns Number: 012721295

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

SleepWeaver 3D Large Headgear only - B036101517 Catalog Number : 101517

Device Description : SleepWeaver 3D Large Headgear only

Device Class : 2

Duns Number: 012721295

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

Smart Trace Electrodes .080 in - B0361015662 Catalog Number : 1015662

Device Description : Smart Trace Electrodes .080 in., 20 Pairs

Device Class : 2

Duns Number: 012721295

Premarket Exempt : No

Product Code : DRX

Prescription Use : No

Device Count : 1

Smart Trace Electrodes .060 in - B0361015663 Catalog Number : 1015663

Device Description : Smart Trace Electrodes .060 in., 10 Sets of 3

Device Class : 2

Duns Number: 012721295

Premarket Exempt : No

Product Code : DRX

Prescription Use : No

Device Count : 1

SmartMonitor 2PSL w/ Modem - B0361028970 Catalog Number : 1028970

Device Description : SmartMonitor 2PSL w/ Modem

Device Class : 2

Duns Number: 012721295

Premarket Exempt : No

Product Code : NPF, DQA

Prescription Use : Yes

Device Count : 1

SmartMonitor 2PSL w/o Modem - B0361028971 Catalog Number : 1028971

Device Description : SmartMonitor 2PSL w/o Modem

Device Class : 2

Duns Number: 012721295

Premarket Exempt : No

Product Code : DQA, NPF

Prescription Use : Yes

Device Count : 1

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