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United States·US-MF-000010620
Last updated September 17, 2026
About
High-quality respiratory products, including CPAP Masks, NIV masks, Pediatric Masks. Sleep apnea, Homecare, Hospital, Full-face, Nasal masks. Best CPAP masks.
From the manufacturer's own website, in their original language. Source
Information
- Country
- United States
- Address
- 5 Merrill Industrial Drive, Sleepnet Corporation, Hampton, United States
- Website
- www.sleepnetmasks.com
- linkedin.com/company/sleepnethealth
- facebook.com/sleepnethealth
- [email protected]
- Phone
- +1 603 758 6625
- PRRC Contact
- Jennifer Kennedy
- EUDAMED SRN
- US-MF-000010620
- FDA FEI Number
- 1222088
- DUNS Number
- —
Catalogue (402)
Page 9 of 9| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Arie Nasal Vented Mask, Large | 50806 | EUDAMED | Class IIa | Active |
| Ascend Full Face Vented Mask, Medium | 50814 | EUDAMEDFDA UDI | Class IIa | Active |
Related Companies
Authorised Representatives
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Recalls (7)
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 |
|---|---|---|---|---|
| Mar 1, 2024 | Z-1351-2024 | — | open, classified | Update to contraindications and warning language due to CPAP masks containing magnets. |
| Mar 1, 2024 | Z-1355-2024 | — | open, classified | Update to contraindications and warning language due to CPAP masks containing magnets. |
| Mar 1, 2024 | Z-1356-2024 | — | open, classified | Update to contraindications and warning language due to CPAP masks containing magnets. |
| Mar 1, 2024 | Z-1353-2024 | — | open, classified | Update to contraindications and warning language due to CPAP masks containing magnets. |
| Mar 1, 2024 | Z-1354-2024 | — | open, classified | Update to contraindications and warning language due to CPAP masks containing magnets. |
| Mar 1, 2024 | Z-1357-2024 | — | open, classified | Update to contraindications and warning language due to CPAP masks containing magnets. |
| Mar 1, 2024 | Z-1352-2024 | — | open, classified | Update to contraindications and warning language due to CPAP masks containing magnets. |