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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 8 of 9

Device	Model / Reference	Registries	Class	Status
MiniMe 2 Pediatric Nasal Non Vented Mask, Extra Small	60256	FDA UDI	Class II	Active
Ascend Nasal Vented Mask Frame	50205	FDA UDI	Class II	Active
Innova Hospital Nasal Non Vented Mask, s/m	50594	FDA UDI	Class I	Active
Ascend Full Face Vented Mask System	50834	EUDAMEDFDA UDI	Class IIa	Active
iQ Blue Nasal Mask with iQ 3 Point Headgear	50647	EUDAMEDFDA UDI	Class IIa	Active
Arie Nasal Vented Mask, Small	50149	EUDAMED	Class IIa	Active
Ascend Nasal Vented Mask, Large	50189	EUDAMEDFDA UDI	Class IIa	Active
Ascend Full Face Vented Mask, Large	50803	EUDAMEDFDA UDI	Class IIa	Active
iQ Nasal Vented Mask with StableFit Headgear	50655	EUDAMEDFDA UDI	Class IIa	Active
Minime Pediatric Mask	K090935	FDA 510(k)	Class II	Active
Mojo Full Face Vented Mask; Veraseal 2 Full Face Vented Mask; Innova Full Face Vented Mask; Ascend Full Face Vented Mask	K241830	FDA 510(k)	Class II	Active
Mojo 2 Full Face Vented Mask, Veraseal 3 Full Face Vented Mask, V3 Full Face Vented Mask	K190254	FDA 510(k)	Class II	Active
Minime 2 Nasal Mask	K121692	FDA 510(k)	Class II	Active
iQ 2 Nasal Vented Mask; Phantom 2 Nasal Vented Mask	K241469	FDA 510(k)	Class II	Active
The Ims Dpap Mask, Ims Model Number 82000	K953697	FDA 510(k)	Class II	Active
Hard Shell Vented Nasal Mask	K121321	FDA 510(k)	Class II	Active
iQ 2 Nasal Mask, Phantom 2 Nasal Mask	K211274	FDA 510(k)	Class II	Active
Iq Ventilation Nasal Mask	K102317	FDA 510(k)	Class II	Active
Sleepnet Mojo Full Face Mask -small, Model No. 53835, Medium , Model No.53836, Large, Model No. 53837	K060273	FDA 510(k)	Class II	Active
Mojo Full Face Non-Vented Mask; Veraseal 2 Full Face Non-Vented Mask; Veraseal 2 Full Face AAV Non-Vented Mask	K241943	FDA 510(k)	Class II	Active
Mojo 2 Full Face Vented Mask; Veraseal 3 Full Face Vented Mask; V3 Full Face Vented Mask	K241661	FDA 510(k)	Class II	Active
Sleepnet Humidifier, (84200 Packaged)	K963025	FDA 510(k)	Class II	Active
Dpap Stealth Sleepnet Model Number 84000	K962713	FDA 510(k)	Class II	Active
Iq Nasal Mask, Model 50160 Rev. D	K021534	FDA 510(k)	Class II	Active
Innova Nasal Non-Vented Mask	K203601	FDA 510(k)	Class II	Active
Iq Nasal Mask, Model P/N 50160	K993269	FDA 510(k)	Class II	Active
Mojo, Veraseal	K120463	FDA 510(k)	Class II	Active
Minime Nasal Mask, Model P/N 50220	K013306	FDA 510(k)	Class II	Active
Ascend Nasal Vented Mask, Medium	50188	EUDAMEDFDA UDI	Class IIa	Active
Ascend Full Face Vented Mask, Medium	50802	EUDAMEDFDA UDI	Class IIa	Active
Ascend Full Face Vented Mask System	50825	EUDAMEDFDA UDI	Class IIa	Active
Mojo 2 Full Face Vented Mask, Large	50819	EUDAMEDFDA UDI	Class IIa	Active
Ascend Full Face Vented Mask, Small	50801	EUDAMEDFDA UDI	Class IIa	Active
Aura Nasal Vented Mask, Medium	50177	EUDAMEDFDA UDI	Class IIa	Active
Aura Nasal Vented Mask, Large	50178	EUDAMEDFDA UDI	Class IIa	Active
Ascend Full Face Vented Mask, Small	50813	EUDAMEDFDA UDI	Class IIa	Active
Mojo 2 Full Face Vented Mask, Medium	50818	EUDAMEDFDA UDI	Class IIa	Active
Ascend Full Face Vented Mask with Multi-Size Cushions	50826	EUDAMEDFDA UDI	Class IIa	Active
Mojo 2 Full Face Vented Mask, Small	50817	EUDAMEDFDA UDI	Class IIa	Active
Mojo 2 Full Face Non Vented Mask, Small	50912	EUDAMEDFDA UDI	Class IIa	Active
Arie Nasal Vented Mask Kit	50851	EUDAMED	Class IIa	Active
Arie Full Face Vented Mask, Small	50804	EUDAMED	Class IIa	Active
Ascend Nasal Vented Mask System	50174	EUDAMEDFDA UDI	Class IIa	Active
Arie Nasal Vented Mask, Medium	50150	EUDAMED	Class IIa	Active
Mojo 2 Full Face AAV Non Vented Mask, Small	50941	EUDAMEDFDA UDI	Class IIa	Active
Aura Nasal Vented Mask, Small	50176	EUDAMEDFDA UDI	Class IIa	Active
Ascend Full Face Vented Mask, Large	50815	EUDAMEDFDA UDI	Class IIa	Active
Mojo 2 Full Face Vented Mask, Extra Large	50820	EUDAMEDFDA UDI	Class IIa	Active
Arie Nasal Vented Mask, Large	50151	EUDAMED	Class IIa	Active
Ascend Nasal Vented Mask, Small	50187	EUDAMEDFDA UDI	Class IIa	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.