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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 6 of 9

Device	Model / Reference	Registries	Class	Status
iQ Blue Nasal Mask with Mask Tubing Assembly	50160-01	FDA UDI	Class II	Active
Veraseal 2 Full Face Vented Mask, Large	50829	FDA UDI	Class II	Active
Mojo Non Vented Full Face Mask, Medium with Headgear	50921	FDA UDI	Class II	Active
Mojo Full Face Mask, Medium with Headgear	50836	FDA UDI	Class II	Active
Varifit NIV Vented Mask With Anti-Asphyxiation Valve, Large Adult	22620	FDA UDI	Class II	Active
Veraseal 2 Full Face Non Vented Mask, Large	50926	FDA UDI	Class II	Active
Varifit NIV Non Vented Mask, Medium Adult	22660	FDA UDI	Class II	Active
Veraseal 2 Full Face Non Vented Mask, Small	50924	FDA UDI	Class II	Active
Ascend Full Face Vented Mask, Small	50813	FDA UDI	Class II	Active
MiniMe Pediatric Mask with Headgear, Size Large	60215	FDA UDI	Class II	Active
V3 Full Face Vented Mask, Medium	50864	FDA UDI	Class II	Active
Mojo 2 Full Face Vented Mask, Large	50819	FDA UDI	Class II	Active
Veraseal 2 Full Face Vented Mask, Medium	50828	FDA UDI	Class II	Active
Ascend Full Face Vented Mask, Large	50815	FDA UDI	Class II	Active
Mojo 2 Full Face Vented Mask, Small	50817	FDA UDI	Class II	Active
Ascend Nasal Vented Mask, Large	50159	FDA UDI	Class II	Active
Varifit NIV Non Vented Mask, Extra Large Adult	22790	EUDAMEDFDA UDI	Class II	Active
Mojo Full Face Mask, Extra Large with Headgear	50838	FDA UDI	Class II	Active
MiniMe 2 Pediatric Nasal Non Vented Mask, M/L	60260	FDA UDI	Class II	Unknown
iQ Blue Nasal Mask with iQ StableFit Headgear	50655-01	FDA UDI	Class II	Active
Mojo Non Vented Full Face Mask, Medium with Headgear	50921	FDA UDI	Class II	Active
Ascend Full Face Vented Mask, Large	50803	FDA UDI	Class II	Active
Mojo Non Vented Full Face Mask, Large with Headgear	50922	FDA UDI	Class II	Active
MiniMe 2 Pediatric Nasal Non Vented Mask, M/L	60260	FDA UDI	Class II	Active
Varifit NIV Vented Mask With Anti-Asphyxiation Valve, Small Adult	22600	FDA UDI	Class II	Active
MiniMe 2 Pediatric Nasal Vented Mask, M/L	60218	FDA UDI	Class II	Unknown
MiniMe 2 Pediatric Nasal Vented Mask, S/M	60217	FDA UDI	Class II	Active
Innova Hospital Nasal Non Vented Mask, m/l	50595	FDA UDI	Class I	Active
MiniMe Pediatric Ventilation Mask with Headgear, Size Small	60253	FDA UDI	Class II	Active
Veraseal 2 Full Face Non Vented Mask, Medium	50934	FDA UDI	Class II	Active
MiniMe Pediatric Ventilation Mask with Headgear, Size Large	60255	FDA UDI	Class II	Active
Mojo 2 Full Face AAV Non Vented Mask, XL	50944	FDA UDI	Class II	Active
Veraseal 2 Full Face AAV Non Vented Mask, Medium	50938	FDA UDI	Class II	Active
FitStar Full Face AAV Non Vented Mask, Extra Large	10711	FDA UDI	Class II	Active
IQ 2 Nasal Vented Mask	50169	FDA UDI	Class II	Active
Ascend Full Face Vented Mask System	50825	FDA UDI	Class II	Active
Novaplus Full Face Non Vented Mask, Small	50916	FDA UDI	Class II	Active
Ascend Nasal Vented Mask with Multi-Size Cushions	50175	FDA UDI	Class II	Active
Mojo 2 Full Face AAV Non Vented Mask, Large	50943	FDA UDI	Class II	Active
Veraseal 3 Full Face Vented Mask, Medium	50844	FDA UDI	Class II	Active
Novaplus Pediatric Nasal Non Vented Mask, Large	60252	FDA UDI	Class II	Active
Mojo 2 Full Face Non Vented Mask, Large	50914	FDA UDI	Class II	Active
Mojo 2 Full Face Non Vented Mask, Small	50912	FDA UDI	Class II	Active
iQ Blue Ventilation Mask & iQ 3 Point Headgear	50660	FDA UDI	Class II	Active
Mojo 2 Full Face Vented Mask, Small	50817	FDA UDI	Class II	Active
Mojo Full Face Mask, Small with Headgear	50835	FDA UDI	Class II	Active
Mojo Non Vented Full Face Mask, Small with Headgear	50920	FDA UDI	Class II	Active
Ascend Nasal Vented Mask, Medium	50158	FDA UDI	Class II	Active
Mojo 2 Full Face AAV Non Vented Mask, XL	50944	FDA UDI	Class II	Active
FitStar Hospital Nasal Non Vented Mask, m/l	50597	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.