Mojo Full Face Vented Mask; Veraseal 2 Full Face Vented Mask; Innova Full Face Vented Mask; Ascend Full Face Vented Mask
Sleepnet Corporation
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 1222088 | 1222088 | SLEEPNET CORPORATION | 1 | N | 2026-01-01 | 5 MERRILL INDUSTRIAL DRIVE Hampton NH US 03842 |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00814747024676 | Arie Nasal Vented Mask, Small - Nasal vented mask for use in positive pressure ventilation. | 1-800-742-3646 | xxx@xx.xx |
| 00814747024683 | Arie Nasal Vented Mask, Medium - Nasal vented mask for use in positive pressure ventilation. | 1-800-742-3646 | xxx@xx.xx |
| 00814747024690 | Arie Nasal Vented Mask, Large - Nasal vented mask for use in positive pressure ventilation. | 1-800-742-3646 | xxx@xx.xx |
| 00814747024706 | Arie Nasal Vented Mask Kit - Nasal vented mask for use in positive pressure ventilation. | 1-800-742-3646 | xxx@xx.xx |
| 00814747024713 | Arie Full Face Vented Mask, Small - Full face vented mask for use in positive pressure ventilation. | 1-800-742-3646 | xxx@xx.xx |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 74296 | 1108439391 | K251847 | Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented Mask | BZD | 2026-01-15 |
| 74296 | 1391796290 | K241943 | Mojo Full Face Non-Vented Mask; Veraseal 2 Full Face Non-Vented Mask; Veraseal 2 Full Face AAV Non-Vented Mask | CBK | 2024-08-28 |
| 74296 | 1929062268 | K241830 | Mojo Full Face Vented Mask; Veraseal 2 Full Face Vented Mask; Innova Full Face Vented Mask; Ascend Full Face Vented Mask | BZD | 2024-10-18 |
| 74296 | 1832729532 | K241661 | Mojo 2 Full Face Vented Mask; Veraseal 3 Full Face Vented Mask; V3 Full Face Vented Mask | BZD | 2024-07-10 |
| 74296 | 1775632669 | K241520 | Mojo 2 Full Face Non-Vented Mask; Mojo 2 Full Face AAV Non-Vented Mask; Veraseal 3 Full Face Non-Vented Mask; Veraseal 3 Full Face AAV Non-Vented Mask | CBK | 2024-06-27 |
| 74296 | 1706756030 | K241469 | iQ 2 Nasal Vented Mask; Phantom 2 Nasal Vented Mask | BZD | 2024-06-15 |
| 74296 | 1711951186 | K203601 | Innova Nasal Non-Vented Mask | BZD | 2021-04-30 |
| 74296 | 1765217025 | K190533 | Mojo 2 Full Face Non-Vented Mask, Mojo 2 AAV Non-Vented Full-Face Mask, Veraseal 3 Full Face Non-Vented Mask, Veraseal 3 Full Face AAV Non-Vented | CBK | 2019-07-26 |
| 74296 | 1344695128 | K190254 | Mojo 2 Full Face Vented Mask, Veraseal 3 Full Face Vented Mask, V3 Full Face Vented Mask | BZD | 2019-07-05 |
| 74296 | 1827618114 | K121692 | MINIME 2 NASAL MASK | BZD | 2012-11-05 |
| 74296 | 1294397945 | K121321 | HARD SHELL VENTED NASAL MASK | BZD | 2012-11-30 |
| 74296 | 1896499723 | K120463 | MOJO, VERASEAL | BZD | 2012-07-27 |
| 74296 | 1278615474 | K102317 | IQ VENTILATION NASAL MASK | BZD | 2011-05-17 |
| 74296 | 1424843016 | K090935 | MINIME PEDIATRIC MASK | BZD | 2009-07-01 |
| 74296 | 1596680692 | K063806 | SLEEPNET MOJO -NV FULL FACE MASK, NON-VENTED | CBK | 2007-05-17 |
| 74296 | 1669274874 | K021534 | IQ NASAL MASK, MODEL 50160 REV. D | BZD | 2002-07-02 |
| 74296 | 1212714433 | ||||
| 74296 | 1537494379 | ||||
| 74296 | 1549990128 | ||||
| 74296 | 1978206786 |
Sleepnet Corporation
Sleepnet Corporation
Sleepnet Corporation
Sleepnet Corporation
Sleepnet Corporation
Sleepnet Corporation
Sleepnet Corporation
Sleepnet Corporation
Sleepnet Corporation
SLEEPNET CORPORATION
SLEEPNET CORPORATION
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SLEEPNET CORPORATION
SLEEPNET CORPORATION
SLEEPNET CORPORATION
SLEEPNET CORPORATION
Sleepnet Corporation
SLEEPNET CORPORATION
SLEEPNET CORPORATION
SLEEPNET CORPORATION
SLEEPNET CORPORATION
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