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Circadiance

Last updated September 17, 2026

Information

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

Catalogue (106)

Page 2 of 3

Device	Model / Reference	Registries	Class	Status
SleepWeaver Advance - Mask Only - Camo	100293	FDA UDI	Class II	Active
Smart Trace Electrodes .080 in	1015662	FDA UDI	Class II	Active
SleepWeaver Advance Pediatric - Mask & Headgear - Pink	101326	FDA UDI	Class II	Unknown
SleepWeaver 3D Large Headgear only	101517	FDA UDI	Class II	Active
SleepWeaver Elan - Mask & Headgear - Small - Leopard	100731	FDA UDI	Class II	Active
Synergy E	101483	FDA UDI	Class II	Active
SmartMonitor 2PSL w/o Modem	1028971	FDA UDI	Class II	Active
SleepWeaver Advance Pediatric - Mask & Headgear - Camo	101327	FDA UDI	Class II	Unknown
SleepWeaver Anew - Mask & Headgear - Regular - Blue	100960	FDA UDI	Class II	Active
SmartMonitor 2PSL Hospital Alarm w/ Modem	1038140	FDA UDI	Class II	Active
SleepWeaver Elan - Mask & Headgear - Small - Pink	100729	FDA UDI	Class II	Active
SleepWeaver Advance Pediatric - Mask Only - Biege	101319	FDA UDI	Class II	Unknown
SmartMonitor 2PSL Hospital Alarm w/o Modem	1038141	FDA UDI	Class II	Active
SleepWeaver Advance - Mask Only - Beige	100336	FDA UDI	Class II	Active
SleepWeaver 3D Regular Headgear only	101516	FDA UDI	Class II	Active
SleepWeaver Elan - Mask Only - Large - Leopard	100667	FDA UDI	Class II	Active
Smart Trace Electrodes .060 in	1015663	FDA UDI	Class II	Active
SmartMonitor 2 w/o Modem	4002	FDA UDI	Class II	Active
SleepWeaver Elan - Mask & Headgear - Large - Blue	100482	FDA UDI	Class II	Active
NeoPAP Cannula - M	1078613	FDA UDI	Class II	Active
SleepWeaver Advance Small - Mask & Headgear - Blue	101225	FDA UDI	Class II	Active
SleepWeaver Advance Pediatric - Mask & Headgear - Beige	101324	FDA UDI	Class II	Unknown
SleepWeaver Advance Small - Mask Only - Beige	101229	FDA UDI	Class II	Active
NeoPAP Delivery Circuit Adapter & Sizing Chart	1078582	FDA UDI	Class II	Active
SleepWeaver Elan - Mask Only - Regular - Camo	100656	FDA UDI	Class II	Active
SleepWeaver Anew - Mask & Headgear - Large - Blue	100965	FDA UDI	Class II	Active
SleepWeaver Elan - Mask & Headgear Starter Kit - Blue	100782	FDA UDI	Class II	Active
NeoPAP Cannula - XXS	1110290	FDA UDI	Class II	Active
SleepWeaver Advance - Mask Only - Blue	100289	FDA UDI	Class II	Active
NeoPAP Bonnet - XL	1078539	FDA UDI	Class II	Active
SleepWeaver Advance Pediatric - Mask & Headgear - Leopard	101328	FDA UDI	Class II	Unknown
SleepWeaver 3D Mask only - Blue	101496	FDA UDI	Class II	Active
SmartMonitor 2PS w/ Modem	1014557	FDA UDI	Class II	Active
SleepWeaver Elan - Mask & Headgear - Small - Beige	100727	FDA UDI	Class II	Active
SleepWeaver Elan - Mask & Headgear - Large - Camo	100484	FDA UDI	Class II	Active
NeoPAP Cannula - L	1078614	FDA UDI	Class II	Active
SleepWeaver Advance Pediatric - Mask Only - Camo	101322	FDA UDI	Class II	Unknown
NeoPAP Cannula - XS	1078611	FDA UDI	Class II	Active
SleepWeaver Anew - Mask Only - Regular - Blue	100975	FDA UDI	Class II	Active
SleepWeaver Anew - Mask & Headgear - Small - Blue	100954	FDA UDI	Class II	Active
SleepWeaver Advance Pediatric - Mask & Headgear - Blue	101325	FDA UDI	Class II	Active
SleepWeaver Elan - Mask Only - Regular - Leopard	100657	FDA UDI	Class II	Active
SleepWeaver Advance - Mask Only - Leopard	100295	FDA UDI	Class II	Active
SleepWeaver Elan - Mask & Headgear - Small - Camo	100730	FDA UDI	Class II	Active
SleepWeaver Elan - Mask & Headgear - Regular - Pink	100520	FDA UDI	Class II	Active
SleepWeaver Elan - Mask & Headgear - Regular - Leopard	100522	FDA UDI	Class II	Active
SleepWeaver Elan - Mask & Headgear - Regular - Blue	100519	FDA UDI	Class II	Active
SleepWeaver Elan - Mask Only - Small - Beige	100742	FDA UDI	Class II	Active
NeoPAP Bonnet - L	1078538	FDA UDI	Class II	Active
SleepWeaver Anew - Mask Only - Small - Blue	100970	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.