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Circadiance

Last updated September 17, 2026

Information

Country: US
Address: 1010 Corporate Lane, Export, PA, 15632
Website: —
LinkedIn: —
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Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 3006182632
DUNS Number: —

Catalogue (106)

Page 1 of 3

Device	Model / Reference	Registries	Class	Status
SleepWeaver Advance Small - Mask & Headgear - Leopard	101228	FDA UDI	Class II	Active
SleepWeaver Advance Pediatric - Mask Only - Blue	101320	FDA UDI	Class II	Active
SleepWeaver Advance - Mask & Headgear - Beige	100332	FDA UDI	Class II	Active
NeoPAP Device - US	1076378	FDA UDI	Class II	Active
SleepWeaver Elan - Mask & Headgear Starter Kit - Beige	100563	FDA UDI	Class II	Active
SleepWeaver Elan - Mask Only - Small - Pink	100744	FDA UDI	Class II	Active
SleepWeaver Advance Small - Mask & Headgear - Camo	101227	FDA UDI	Class II	Active
SleepWeaver Advance Small - Mask Only - Camo	101232	FDA UDI	Class II	Active
NeoPAP Bonnet - S	1078536	FDA UDI	Class II	Active
SleepWeaver Elan - Mask & Headgear - Regular - Beige	100518	FDA UDI	Class II	Active
SleepWeaver Anew - Mask Only - Large - Blue	100980	FDA UDI	Class II	Active
SleepWeaver Elan - Mask & Headgear - Large - Pink	100483	FDA UDI	Class II	Active
SleepWeaver Advance Small - Mask Only - Leopard	101233	FDA UDI	Class II	Active
SleepWeaver Advance - Mask & Headgear - Pink	100277	FDA UDI	Class II	Active
SleepWeaver Elan - Mask Only - Small - Blue	100743	FDA UDI	Class II	Active
SmartMonitor 2PSL w/ Modem	1028970	FDA UDI	Class II	Active
SleepWeaver Elan - Mask Only - Small - Camo	100745	FDA UDI	Class II	Active
NeoPAP Cannula - S	1078612	FDA UDI	Class II	Active
SleepWeaver Advance - Mask & Headgear - Camo	100281	FDA UDI	Class II	Active
SleepWeaver Advance Small - Mask & Headgear - Pink	101226	FDA UDI	Class II	Active
SleepWeaver 3D Mask and Regular Headgear - Blue	101486	FDA UDI	Class II	Active
SleepWeaver Elan - Mask Only - Small - Leopard	100746	FDA UDI	Class II	Active
SmartMonitor 2 w/ Modem	4003	FDA UDI	Class II	Active
SleepWeaver Elan - Mask Only - Large - Beige	100663	FDA UDI	Class II	Active
SleepWeaver Elan - Mask Only - Regular - Pink	100655	FDA UDI	Class II	Active
SleepWeaver Advance Small - Mask & Headgear - Beige	101224	FDA UDI	Class II	Active
NeoPAP Mask - S	1078667	FDA UDI	Class II	Active
SleepWeaver Elan - Mask Only - Large - Camo	100666	FDA UDI	Class II	Active
SleepWeaver Elan - Mask Only - Regular - Beige	100653	FDA UDI	Class II	Active
NeoPAP Bonnet - M	1078537	FDA UDI	Class II	Active
SleepWeaver 3D Mask and Large Headgear - Blue	101491	FDA UDI	Class II	Active
SleepWeaver Advance Small - Mask Only - Pink	101231	FDA UDI	Class II	Active
SleepWeaver Advance - Mask & Headgear - Leopard	100285	FDA UDI	Class II	Active
NeoPAP Cannula - XL	1078616	FDA UDI	Class II	Active
SleepWeaver Anew - Mask & Headgear - Large - Beige	100964	FDA UDI	Class II	Unknown
SleepWeaver Elan - Mask Only - Large - Blue	100664	FDA UDI	Class II	Active
SleepWeaver Advance - Mask Only - Pink	100291	FDA UDI	Class II	Active
NeoPAP Customer Trial Pack	1078602	FDA UDI	Class II	Active
SleepWeaver Advance Small - Mask Only - Blue	101230	FDA UDI	Class II	Active
SleepWeaver Advance - Mask & Headgear - Blue	100274	FDA UDI	Class II	Active
NeoPAP Mask - L	1078668	FDA UDI	Class II	Active
SleepWeaver Elan - Mask Only - Regular - Blue	100654	FDA UDI	Class II	Active
SleepWeaver Elan - Mask & Headgear - Large - Beige	100481	FDA UDI	Class II	Active
SleepWeaver Elan - Mask Only - Large - Pink	100665	FDA UDI	Class II	Active
SleepWeaver Advance Pediatric - Mask Only - Pink	101321	FDA UDI	Class II	Unknown
SleepWeaver Elan - Mask & Headgear - Regular - Camo	100521	FDA UDI	Class II	Active
SleepWeaver Advance Pediatric - Mask Only - Leopard	101323	FDA UDI	Class II	Unknown
SmartMonitor 2PS Hospital Alarm	1030271	FDA UDI	Class II	Active
NeoPAP Bonnet - XS	1078535	FDA UDI	Class II	Active
SleepWeaver Elan - Mask & Headgear - Large - Leopard	100485	FDA UDI	Class II	Active

Related Companies

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FDA Recalls (1)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
May 1, 2017	Z-2250-2017	—	terminated	Circadiance has determined that it is possible for certain Smart Monitor 2PS/PSL monitors to exhibit intermittent operation of the nurse call feature. The firm has updated the device to increase the "Nurse Call" feature to ensure monitor alarms are transmitted to compatible nurse call systems.