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Sleepnet Corporation

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: linkedin.com/company/sleepnethealth
Facebook: facebook.com/sleepnethealth
Email: [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 5 of 9

Device	Model / Reference	Registries	Class	Status
Novaplus Full Face Vented Mask, Small	50867	FDA UDI	Class II	Active
Novaplus Pediatric Nasal Non Vented Mask, Small	60250	FDA UDI	Class II	Active
Mojo Non Vented Full Face Mask, Large with Headgear	50922	FDA UDI	Class II	Active
MiniMe 2 Pediatric Nasal Vented Mask, M/L	60220	FDA UDI	Class II	Active
Aura Nasal Vented Mask, Large	50185	FDA UDI	Class II	Active
Mojo Full Face Mask, Large with Headgear	50837	FDA UDI	Class II	Active
Innova Nasal Non Vented Mask, m/l	50593	FDA UDI	Class I	Active
Novaplus Full Face AAV Non Vented Mask, Large	50947	FDA UDI	Class II	Active
iQ Blue Nasal Mask with iQ 3 Point Headgear	50647-01	FDA UDI	Class II	Active
Veraseal 2 Full Face Non Vented Mask, Large	50935	FDA UDI	Class II	Active
iQ Blue Nasal Mask & 6" Tapered Tubing	50293	FDA UDI	Class II	Active
Veraseal 2 Full Face AAV Non Vented Mask, Extra Large	50940	FDA UDI	Class II	Active
Varifit NIV Non Vented Mask With Anti-Asphyxiation Valve, Large Adult	22690	FDA UDI	Class II	Active
Veraseal 2 Full Face Vented Mask, Small	50821	FDA UDI	Class II	Active
IQ 2 Nasal Vented Mask	50169	FDA UDI	Class II	Active
V3 Full Face Vented Mask, Extra Large	50866	FDA UDI	Class II	Active
iQ Blue Nasal Mask & 6" Tapered Tubing with iQ StableFit Headgear	50255	FDA UDI	Class II	Active
Mojo 2 Full Face AAV Non Vented Mask, Small	50941	FDA UDI	Class II	Active
MiniMe 2 Pediatric Nasal Vented Mask, Large	60221	FDA UDI	Class II	Active
Ascend Full Face Vented Mask System	50834	FDA UDI	Class II	Active
Mojo Full Face Mask, Small with Headgear	50860	FDA UDI	Class II	Unknown
Mojo Non Vented Full Face Mask, Small with Headgear	50920	FDA UDI	Class II	Active
Veraseal 2 Full Face AAV Non Vented Mask, Small	50937	FDA UDI	Class II	Active
iQ Blue Nasal Mask & 6" Tapered Tubing with iQ StableFit Headgear	50255	FDA UDI	Class II	Active
Varifit NIV Non Vented Mask With Anti-Asphyxiation Valve, Extra Large Adult	22780	FDA UDI	Class II	Active
MiniMe Pediatric Ventilation Mask with Headgear, Size Medium	60254	FDA UDI	Class II	Active
Ascend Full Face Vented Mask, Large	50803	FDA UDI	Class II	Active
Veraseal 3 Full Face Vented Mask, Large	50845	FDA UDI	Class II	Active
Ascend Full Face Vented Mask with Multi-Size Cushions	50826	FDA UDI	Class II	Active
Ascend Full Face Airgel Cushion, Medium	50208	FDA UDI	Class II	Active
Mojo 2 Full Face Vented Mask, Extra Large	50820	FDA UDI	Class II	Active
MiniMe Pediatric Mask with Headgear, Size Large	60215	FDA UDI	Class II	Active
Mojo Full Face Mask, Medium with Headgear	50836	FDA UDI	Class II	Active
Aura Nasal Vented Mask, Medium	50177	FDA UDI	Class II	Active
Veraseal 2 Full Face Non Vented Mask, Medium	50925	FDA UDI	Class II	Active
MiniMe Pediatric Mask with Headgear, Size Medium	60214	FDA UDI	Class II	Active
V3 Full Face Vented Mask, Small	50863	FDA UDI	Class II	Active
Varifit NIV Vented Mask With Anti-Asphyxiation Valve, Large Adult	22620	FDA UDI	Class II	Active
Ascend Full Face Vented Mask, Medium	50802	FDA UDI	Class II	Active
Veraseal 3 Full Face Vented Mask, Extra Large	50846	FDA UDI	Class II	Active
Veraseal 2 Full Face Non Vented Mask, Large	50926	FDA UDI	Class II	Active
Veraseal 3 Full Face Non Vented Mask, Medium	50950	FDA UDI	Class II	Active
FitStar Full Face AAV Non Vented Mask, Large	10710	FDA UDI	Class II	Active
FitStar Full Face Vented Mask, Medium	10701	FDA UDI	Class II	Active
Mojo 2 Full Face AAV Non Vented Mask, Medium	50942	FDA UDI	Class II	Active
Ascend Full Face Vented Mask, Small	50801	FDA UDI	Class II	Active
Phantom 2 Nasal Vented Mask	50182	FDA UDI	Class II	Active
Veraseal 2 Full Face Vented Mask, Large	50823	FDA UDI	Class II	Active
Veraseal 2 Full Face Vented Mask, Large	50823	FDA UDI	Class II	Active
Ascend Full Face Vented Mask Frame	50211	FDA UDI	Class II	Active

Related Companies

Authorised Representatives

MPS Medical Product Service GmbH DE

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

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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.