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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
Phone
+1 603 758 6625
PRRC Contact
Jennifer Kennedy
EUDAMED SRN
US-MF-000010620
FDA FEI Number
1222088
DUNS Number
—

Catalogue (403)

Page 1 of 9
DeviceModel / ReferenceRegistriesClassStatus
Ascend Full Face Vented Mask, Medium 50802
FDA UDI
Class IIActive
Varifit NIV Vented Mask With Anti-Asphyxiation Valve, Small Adult 22600
FDA UDI
Class IIActive
Veraseal 2 Full Face Non Vented Mask, Large 50926
FDA UDI
Class IIActive
Innova Nasal Non Vented Mask, s/m 50592
FDA UDI
Class IActive
Novaplus Full Face AAV Non Vented Mask, Medium 50946
FDA UDI
Class IIActive
Mojo 2 Full Face Vented Mask, Extra Large 50820
FDA UDI
Class IIActive
MiniMe Pediatric Ventilation Mask with Headgear, Size Small 60253
FDA UDI
Class IIActive
Mojo 2 Full Face Mask Non Vented Mask, Extra Large 50915
FDA UDI
Class IIActive
Mojo 2 Full Face AAV Non Vented Mask, Medium 50942
FDA UDI
Class IIActive
Veraseal 2 Full Face Vented Mask, Large 50829
FDA UDI
Class IIActive
Mojo 2 Full Face Non Vented Mask, Medium 50913
FDA UDI
Class IIActive
Novaplus Hospital Nasal Vented Mask, s/m 50155
FDA UDI
Class IIActive
Novaplus Pediatric Nasal Vented Mask, Extra Small 60222
FDA UDI
Class IIActive
Ascend Full Face Vented Mask with Multi-Size Cushions 50826
FDA UDI
Class IIActive
Novaplus Full Face Non Vented Mask, Large 50918
FDA UDI
Class IIActive
Mojo 2 Full Face Vented Mask, Extra Large 50820
FDA UDI
Class IIActive
Novaplus Full Face Non Vented Mask, Medium 50917
FDA UDI
Class IIActive
Innova Nasal Non Vented Mask, m/l 50593
FDA UDI
Class IIActive
Veraseal 3 Full Face Non Vented Mask, Extra Large 50952
FDA UDI
Class IIActive
Mojo 2 Full Face AAV Non Vented Mask, Large 50943
FDA UDI
Class IIActive
Veraseal 3 Full Face Vented Mask, Small 50843
FDA UDI
Class IIActive
Mojo Non Vented Full Face Mask, Small with Headgear 50920
FDA UDI
Class IIActive
Veraseal 2 Full Face Non Vented Mask, Small 50924
FDA UDI
Class IIActive
Innova Full Face Vented Mask, Medium 50853
FDA UDI
Class IIActive
Veraseal 2 Full Face Non Vented Mask, Medium 50925
FDA UDI
Class IIActive
Novaplus Full Face AAV Non Vented Mask, Small 50945
FDA UDI
Class IIActive
FitStar Full Face Non Vented Mask, Large 10706
FDA UDI
Class IIActive
iQ Blue Ventilation Mask & iQ 3 Point Headgear 50660
FDA UDI
Class IIActive
Innova Nasal Non Vented Mask, S/M 50592
FDA UDI
Class IIActive
Veraseal 2 Full Face Non Vented Mask, Medium 50925
FDA UDI
Class IIActive
Ascend Full Face Vented Mask, Medium 50814
FDA UDI
Class IIUnknown
Ascend Full Face Vented Mask, Small 50813
FDA UDI
Class IIActive
FitStar Full Face Vented Mask, Large 10702
FDA UDI
Class IIActive
MiniMe 2 Pediatric Nasal Vented Mask, Extra Small 60216
FDA UDI
Class IIActive
MiniMe Pediatric Mask with Headgear, Size Large 60215
FDA UDI
Class IIActive
Novaplus Full Face AAV Non Vented Mask, Large 50947
FDA UDI
Class IIActive
Innova Hospital Nasal Non Vented Mask, s/m 50594
FDA UDI
Class IIActive
Novaplus Full Face Non Vented Mask, Large 50918
FDA UDI
Class IIActive
Novaplus Pediatric Nasal Non Vented Mask, Medium 60251
FDA UDI
Class IIActive
Novaplus Full Face Non Vented Mask, Extra Large 50919
FDA UDI
Class IIActive
Novaplus Full Face AAV Non Vented Mask, Extra Large 50948
FDA UDI
Class IIActive
Mojo Full Face Mask, Small with Headgear 50835
FDA UDI
Class IIActive
Mojo 2 Full Face Mask Non Vented Mask, Extra Large 50915
FDA UDI
Class IIActive
Mojo 2 Full Face Vented Mask, Medium 50818
FDA UDI
Class IIActive
Mojo Full Face Mask, Extra Large with Headgear 50838
FDA UDI
Class IIActive
Ascend Full Face Vented Mask System 50825
FDA UDI
Class IIActive
Veraseal 2 Full Face Non Vented Mask, Large 50935
FDA UDI
Class IIActive
Innova Full Face Vented Mask, Medium 50853
FDA UDI
Class IIUnknown
MiniMe Pediatric Ventilation Mask with Headgear, Size Medium 60254
FDA UDI
Class IIActive
Ascend Nasal Vented Mask, Large 50189
FDA UDI
Class IIActive

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Authorities

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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.

DateRecall No.ClassStatusReason
Mar 1, 2024Z-1351-2024—open, classified

Update to contraindications and warning language due to CPAP masks containing magnets.

Mar 1, 2024Z-1355-2024—open, classified

Update to contraindications and warning language due to CPAP masks containing magnets.

Mar 1, 2024Z-1356-2024—open, classified

Update to contraindications and warning language due to CPAP masks containing magnets.

Mar 1, 2024Z-1353-2024—open, classified

Update to contraindications and warning language due to CPAP masks containing magnets.

Mar 1, 2024Z-1354-2024—open, classified

Update to contraindications and warning language due to CPAP masks containing magnets.

Mar 1, 2024Z-1357-2024—open, classified

Update to contraindications and warning language due to CPAP masks containing magnets.

Mar 1, 2024Z-1352-2024—open, classified

Update to contraindications and warning language due to CPAP masks containing magnets.