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Sign in to claim this brandCircadiance
US
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 3 of 3| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| SleepWeaver Elan - Mask & Headgear - Small - Blue | 100728 | FDA UDI | Class II | Active |
| Sleepweaver Nasal Cpap Mask | K092362 | FDA 510(k) | Class II | Active |
| SleepWeaver 3D Nasal Mask | K162905 | FDA 510(k) | Class II | Active |
| SleepWeaver Advance Pediatric Nasal CPAP Mask | K151683 | FDA 510(k) | Class II | Active |
| Sleepweaver Anew Full Face Soft Cloth Pap Mask | K130481 | FDA 510(k) | Class II | Active |
| Sleepweaver Elan Nasal Cpap Mask | K120757 | FDA 510(k) | Class II | Active |
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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. |