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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 2 of 9

Device	Model / Reference	Registries	Class	Status
Mojo Full Face Mask, Large with Headgear	50837	FDA UDI	Class II	Active
Veraseal 2 Full Face Vented Mask, Medium	50822	FDA UDI	Class II	Active
Ascend Full Face Vented Mask, Small	50813	FDA UDI	Class II	Active
Veraseal 3 Full Face AAV Non Vented Mask, Medium	50954	FDA UDI	Class II	Active
Mojo 2 Full Face Vented Mask, Medium	50818	FDA UDI	Class II	Active
iQ Blue Nasal Mask with iQ 3 Point Headgear	50647	FDA UDI	Class II	Active
Mojo 2 Full Face AAV Non Vented Mask, XL	50944	FDA UDI	Class II	Active
Mojo Non Vented Full Face Mask, Large with Headgear	50922	FDA UDI	Class II	Active
MiniMe Pediatric Mask with Headgear, Size Medium	60214	FDA UDI	Class II	Active
MiniMe Pediatric Ventilation Mask with Headgear, Size Small	60253	FDA UDI	Class II	Active
iQ Blue Nasal Mask with iQ 3 Point Headgear	50647-01	FDA UDI	Class II	Active
Ascend Full Face Vented Mask, Large	50815	FDA UDI	Class II	Unknown
Ascend Nasal Airgel Cushion Medium	50202	FDA UDI	Class II	Active
Varifit NIV Non Vented Mask With Anti-Asphyxiation Valve, Large Adult	22690	FDA UDI	Class II	Active
Innova Full Face Vented Mask, Large	50854	FDA UDI	Class II	Unknown
Mojo Full Face Mask, Large with Headgear	50837	FDA UDI	Class II	Active
Ascend Full Face Vented Mask, Large	50815	FDA UDI	Class II	Active
FitStar Full Face Non Vented Mask, Medium	10705	FDA UDI	Class II	Active
Ascend Full Face Vented Mask, Medium	50814	FDA UDI	Class II	Active
Varifit NIV Non Vented Mask, Large Adult	22670	FDA UDI	Class II	Active
Varifit NIV Non Vented Mask, Small Adult	22650	FDA UDI	Class II	Active
Ascend Full Face Vented Mask, Small	50801	FDA UDI	Class II	Active
IQ 2 Nasal Vented Mask	50169	FDA UDI	Class II	Active
Veraseal 2 Full Face AAV Non Vented Mask, Medium	50938	FDA UDI	Class II	Active
Veraseal 3 Full Face AAV Non Vented Mask, Small	50953	FDA UDI	Class II	Active
Novaplus Full Face Non Vented Mask, Medium	50917	FDA UDI	Class II	Active
Varifit NIV Non Vented Mask With Anti-Asphyxiation Valve, Large Adult	22690	FDA UDI	Class II	Active
Mojo Non Vented Full Face Mask, Large with Headgear	50922	FDA UDI	Class II	Active
Novaplus Hospital Nasal Vented Mask, m/l	50156	FDA UDI	Class II	Active
Veraseal 2 Full Face Non Vented Mask, Medium	50934	FDA UDI	Class II	Active
Veraseal 2 Full Face Non Vented Mask, Extra Large	50936	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 Mask with Headgear, Size Medium	60214	FDA UDI	Class II	Active
iQ Blue Ventilation Nasal Mask with iQ StableFit Headgear	50575	FDA UDI	Class II	Active
Novaplus Full Face AAV Non Vented Mask, Small	50945	FDA UDI	Class II	Active
Ascend Nasal Mask System	50174	FDA UDI	Class II	Unknown
Varifit NIV Non Vented Mask, Large Adult	22670	FDA UDI	Class II	Active
Ascend Full Face Airgel Cushion, Small	50207	FDA UDI	Class II	Active
FitStar Full Face Non Vented Mask, Small	10704	FDA UDI	Class II	Active
Mojo 2 Full Face AAV Non Vented Mask, Small	50941	FDA UDI	Class II	Active
MiniMe 2 Pediatric Nasal Non Vented Mask, M/L	60258	FDA UDI	Class II	Active
Mojo 2 Full Face Non Vented Mask, Medium	50913	FDA UDI	Class II	Active
Mojo Full Face Mask, Medium with Headgear	50836	FDA UDI	Class II	Active
Innova Nasal Non Vented Mask, s/m	50592	FDA UDI	Class I	Unknown
Varifit NIV Vented Mask With Anti-Asphyxiation Valve, Medium Adult	22610	FDA UDI	Class II	Active
Novaplus Full Face Non Vented Mask, Small	50916	FDA UDI	Class II	Active
MiniMe Pediatric Mask with Headgear, Size Small	60213	FDA UDI	Class II	Active
iQ Blue Ventilation Mask	50590	FDA UDI	Class II	Active
Novaplus Full Face Vented Mask, Extra Large	50870	FDA UDI	Class II	Active
Veraseal 2 Full Face Vented Mask, Extra Large	50824	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

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.