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) (7) Monitor, Apnea, Home Use (NPF) (3) Oximeter (DQA) (3)

Premarket Exempt

Clear

SmartMonitor 2PS Hospital Alarm - B0361030271 Catalog Number : 1030271

Device Description : SmartMonitor 2PS Hospital Alarm

Device Class : 2

Duns Number: 012721295

Premarket Exempt : No

Product Code : NPF, DQA

Prescription Use : Yes

Device Count : 1

SmartMonitor 2PSL Hospital Alarm w/ Modem - B0361038140 Catalog Number : 1038140

Device Description : SmartMonitor 2PSL Hospital Alarm w/ Modem

Device Class : 2

Duns Number: 012721295

Premarket Exempt : No

Product Code : DQA, NPF

Prescription Use : Yes

Device Count : 1

SmartMonitor 2PSL Hospital Alarm w/o Modem - B0361038141 Catalog Number : 1038141

Device Description : SmartMonitor 2PSL Hospital Alarm w/o Modem

Device Class : 2

Duns Number: 012721295

Premarket Exempt : No

Product Code : NPF, DQA

Prescription Use : Yes

Device Count : 1

NeoPAP Device - US - B0361076378 Catalog Number : 1076378

Device Description : NeoPAP Device - US

Device Class : 2

Duns Number: 012721295

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

NeoPAP Bonnet - XS - B0361078535 Catalog Number : 1078535

Device Description : NeoPAP Bonnet - XS

Device Class : 2

Duns Number: 012721295

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

NeoPAP Bonnet - S - B0361078536 Catalog Number : 1078536

Device Description : NeoPAP Bonnet - S

Device Class : 2

Duns Number: 012721295

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

NeoPAP Bonnet - M - B0361078537 Catalog Number : 1078537

Device Description : NeoPAP Bonnet - M

Device Class : 2

Duns Number: 012721295

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

NeoPAP Bonnet - L - B0361078538 Catalog Number : 1078538

Device Description : NeoPAP Bonnet - L

Device Class : 2

Duns Number: 012721295

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

NeoPAP Bonnet - XL - B0361078539 Catalog Number : 1078539

Device Description : NeoPAP Bonnet - XL

Device Class : 2

Duns Number: 012721295

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

NeoPAP Delivery Circuit Adapter & Sizing Chart - B0361078582 Catalog Number : 1078582

Device Description : NeoPAP Delivery Circuit Adapter & Sizing Chart

Device Class : 2

Duns Number: 012721295

Premarket Exempt : No

Product Code : BZD

Prescription Use : Yes

Device Count : 1

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