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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 3 of 9

Device	Model / Reference	Registries	Class	Status
Mojo 2 Full Face Vented Mask, Small	50817	FDA UDI	Class II	Active
Mojo Non Vented Full Face Mask, Large with Headgear	50922	FDA UDI	Class II	Active
Novaplus Full Face AAV Non Vented Mask, Extra Large	50948	FDA UDI	Class II	Active
Novaplus Pediatric Nasal Vented Mask, Large	60225	FDA UDI	Class II	Active
Aura Nasal Vented Mask, Medium	50184	FDA UDI	Class II	Unknown
MiniMe 2 Pediatric Nasal Non Vented Mask, Large	60261	FDA UDI	Class II	Active
Innova Hospital Nasal Non Vented Mask, m/l	50595	FDA UDI	Class II	Active
Mojo Non Vented Full Face Mask, Small with Headgear	50920	FDA UDI	Class II	Active
Varifit NIV Non Vented Mask With Anti-Asphyxiation Valve, Medium Adult	22640	FDA UDI	Class II	Active
Ascend Full Face Vented Mask, Medium	50814	FDA UDI	Class II	Active
Mojo Full Face Mask, Extra Large with Headgear	50838	FDA UDI	Class II	Active
Mojo 2 Full Face Non Vented Mask, Large	50914	FDA UDI	Class II	Active
Veraseal 2 Full Face Vented Mask, Extra Large	50830	FDA UDI	Class II	Active
Innova Nasal Vented Mask, m/l	50163	FDA UDI	Class II	Active
Varifit NIV Non Vented Mask With Anti-Asphyxiation Valve, Small Adult	22630	FDA UDI	Class II	Active
Mojo 2 Full Face Vented Mask, Medium	50818	FDA UDI	Class II	Active
Mojo 2 Full Face Non Vented Mask, Small	50912	FDA UDI	Class II	Active
Veraseal 2 Full Face Non Vented Mask, Extra Large	50927	FDA UDI	Class II	Active
Mojo Non Vented Full Face Mask, Extra Large with Headgear	50923	FDA UDI	Class II	Active
Veraseal 3 Full Face AAV Non Vented Mask, Extra Large	50956	FDA UDI	Class II	Active
Veraseal 2 Full Face Non Vented Mask, Small	50933	FDA UDI	Class II	Active
Ascend Nasal Vented Mask, Medium	50188	FDA UDI	Class II	Active
MiniMe 2 Pediatric Nasal Vented Mask, S/M	60219	FDA UDI	Class II	Active
Ascend Full Face Airgel Cushion, Large	50209	FDA UDI	Class II	Active
FitStar Full Face AAV Non Vented Mask, Small	10708	FDA UDI	Class II	Active
Mojo 2 Full Face Non Vented Mask, Medium	50913	FDA UDI	Class II	Active
MiniMe Pediatric Ventilation Mask with Headgear, Size Medium	60254	FDA UDI	Class II	Active
Varifit NIV Vented Mask With Anti-Asphyxiation Valve, Extra Large Adult	22770	FDA UDI	Class II	Active
Aura Nasal Vented Mask, Small	50176	FDA UDI	Class II	Unknown
Mojo Non Vented Full Face Mask, Small with Headgear	50920	FDA UDI	Class II	Active
Ascend Nasal Airgel Cushion Large	50203	FDA UDI	Class II	Active
FitStar Hospital Nasal Vented Mask, m/l	50193	FDA UDI	Class II	Active
Innova Hospital Nasal Vented Mask, s/m	50180	FDA UDI	Class II	Active
Mojo Full Face Mask, Medium with Headgear	50861	FDA UDI	Class II	Unknown
Veraseal 2 Full Face AAV Non Vented Mask, Large	50939	FDA UDI	Class II	Active
Ascend Nasal Vented Mask, Small	50187	FDA UDI	Class II	Unknown
Mojo Non Vented Full Face Mask, Extra Large with Headgear	50923	FDA UDI	Class II	Active
Veraseal 2 Full Face AAV Non Vented Mask, Small	50937	FDA UDI	Class II	Active
Veraseal 2 Full Face Non Vented Mask, Extra Large	50936	FDA UDI	Class II	Active
iQ Blue Nasal Mask & 6" Tapered Tubing with iQ StableFit Headgear	50255	FDA UDI	Class II	Active
Veraseal 2 Full Face Non Vented Mask, Small	50933	FDA UDI	Class II	Active
Ascend Nasal Vented Mask, Large	50159	FDA UDI	Class II	Active
Mojo 2 Full Face AAV Non Vented Mask, Large	50943	FDA UDI	Class II	Active
iQ Blue Nasal Mask with iQ StableFit Headgear	50655-01	FDA UDI	Class II	Active
Veraseal 2 Full Face AAV Non Vented Mask, Large	50939	FDA UDI	Class II	Active
Ascend Nasal Vented Mask, Small	50187	FDA UDI	Class II	Active
Veraseal 2 Full Face Non Vented Mask, Extra Large	50927	FDA UDI	Class II	Active
Innova Full Face Vented Mask, Small	50852	FDA UDI	Class II	Unknown
Mojo Full Face Mask, Medium with Headgear	50836	FDA UDI	Class II	Active
Innova Nasal Non Vented Mask, m/l	50593	FDA UDI	Class I	Unknown

Related Companies

Authorised Representatives

MPS Medical Product Service GmbH DE

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.