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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 7 of 9

Device	Model / Reference	Registries	Class	Status
Novaplus Full Face Non Vented Mask, Extra Large	50919	FDA UDI	Class II	Active
Mojo 2 Full Face AAV Non Vented Mask, XL	50944	FDA UDI	Class II	Active
Mojo 2 Full Face AAV Non Vented Mask, Medium	50942	FDA UDI	Class II	Active
Mojo 2 Full Face AAV Non Vented Mask, Small	50941	FDA UDI	Class II	Active
Veraseal 2 Full Face Non Vented Mask, Medium	50934	FDA UDI	Class II	Active
Mojo 2 Full Face Non Vented Mask, Large	50914	FDA UDI	Class II	Active
Innova Nasal Vented Mask, m/l	50163	FDA UDI	Class II	Unknown
MiniMe 2 Pediatric Nasal Vented Mask, Medium	60218	FDA UDI	Class II	Active
Novaplus Pediatric Nasal Vented Mask, Small	60223	FDA UDI	Class II	Active
MiniMe Pediatric Mask with Headgear, Size Small	60213	FDA UDI	Class II	Active
Mojo Full Face Mask, Large with Headgear	50862	FDA UDI	Class II	Unknown
Varifit NIV Non Vented Mask, Large Adult	22670	FDA UDI	Class II	Active
Novaplus Full Face Vented Mask, Large	50869	FDA UDI	Class II	Active
Mojo Non Vented Full Face Mask, Medium with Headgear	50921	FDA UDI	Class II	Active
iQ Blue Nasal Mask with iQ StableFit Headgear	50655	FDA UDI	Class II	Active
MiniMe 2 Pediatric Nasal Vented Mask, M/L	60218	FDA UDI	Class II	Active
Veraseal 2 Full Face Vented Mask, Medium	50822	FDA UDI	Class II	Active
MiniMe 2 Pediatric Nasal Non Vented Mask, S/M	60259	FDA UDI	Class II	Active
iQ Blue Nasal Mask with Mask Tubing Assembly	50160	FDA UDI	Class II	Active
Mojo 2 Full Face Non Vented Mask, Large	50914	FDA UDI	Class II	Active
Mojo 2 Full Face AAV Non Vented Mask, Medium	50942	EUDAMEDFDA UDI	Class II	Active
Mojo Full Face Mask, Large with Headgear	50837	FDA UDI	Class II	Active
Phantom 2 Nasal Vented Mask	50182	FDA UDI	Class II	Active
Ascend Nasal Vented Mask System	50179	EUDAMEDFDA UDI	Class II	Active
Mojo Non Vented Full Face Mask, Extra Large with Headgear	50923	FDA UDI	Class II	Active
FitStar Full Face AAV Non Vented Mask, Medium	10709	FDA UDI	Class II	Active
Mojo Non Vented Full Face Mask, Extra Large with Headgear	50923	FDA UDI	Class II	Active
Varifit NIV Non Vented Mask, Medium Adult	22660	FDA UDI	Class II	Active
MiniMe 2 Pediatric Nasal Vented Mask, M/L	60220	FDA UDI	Class II	Unknown
Mojo Full Face Mask, Extra Large with Headgear	50838	FDA UDI	Class II	Active
Novaplus Full Face Vented Mask, Medium	50868	FDA UDI	Class II	Active
MiniMe 2 Pediatric Nasal Non Vented Mask, M/L	60258	FDA UDI	Class II	Unknown
MiniMe 2 Pediatric Nasal Vented Mask, Small	60217	FDA UDI	Class II	Active
MiniMe 2 Pediatric Nasal Non Vented Mask, S/M	60257	FDA UDI	Class II	Active
MiniMe Pediatric Mask with Headgear, Size Small	60213	FDA UDI	Class II	Active
Novaplus Pediatric Nasal Non Vented Mask, Extra Small	60249	FDA UDI	Class II	Active
Mojo Non Vented Full Face Mask, Extra Large with Headgear	50923	FDA UDI	Class II	Active
Novaplus Hospital Nasal Non Vented Mask, s/m	50588	FDA UDI	Class II	Active
Mojo Full Face Mask, Small with Headgear	50835	FDA UDI	Class II	Active
MiniMe Pediatric Ventilation Mask with Headgear, Size Large	60255	FDA UDI	Class II	Active
Varifit NIV Non Vented Mask With Anti-Asphyxiation Valve, Small Adult	22630	FDA UDI	Class II	Active
Novaplus Full Face AAV Non Vented Mask, Medium	50946	FDA UDI	Class II	Active
Varifit NIV Vented Mask With Anti-Asphyxiation Valve, Medium Adult	22610	FDA UDI	Class II	Active
Ascend Nasal Airgel Cushion Small	50201	FDA UDI	Class II	Active
Mojo Full Face Mask, Extra Large with Headgear	50838	FDA UDI	Class II	Active
Innova Hospital Nasal Vented Mask, m/l	50181	FDA UDI	Class II	Active
Varifit NIV Non Vented Mask With Anti-Asphyxiation Valve, Medium Adult	22640	FDA UDI	Class II	Active
Mojo Non Vented Full Face Mask, Medium with Headgear	50921	FDA UDI	Class II	Active
Innova Full Face Vented Mask, Small	50852	FDA UDI	Class II	Active
Novaplus Hospital Nasal Non Vented Mask, m/l	50589	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.